Description: About our company: Bakerly, a happy family-owned company, is proud to be home to one of the fastest-growing brands in the US food industry! We are a baked goods manufacturer that emphasizes delicious, premium, and authentic recipes using only the very best ingredients. Our offices located in Miami, FL, Easton, PA, and San Antonio, TX, will make you feel right at home. Please visit our website to learn more about our delicious French crêpes, golden chocolate croissants, fluffy pancakes, and our large range of outstanding French brioches. Job Description: Scope/Purpose of the Position The purpose of this position is to lead and support the maintenance team in ensuring optimal functionality of all production, packaging, and warehouse equipment. This role encompasses daily supervision of maintenance technicians, execution of preventive maintenance programs, training initiatives, and continuous improvement efforts, contributing to equipment reliability, production efficiency, and adherence to safety and GMP standards in a high-speed manufacturing environment. This position is for Second Shift with the hours of 2pm - 10pm. Key Responsibilities and Essential Functions Primary Duties: - Assign and manage daily work orders and tasks for maintenance technicians; ensure adequate shift coverage and follow-up on progress throughout the shift. - Oversee execution and continuous improvement of the preventive maintenance program; audit completed work and recommend updates based on failure trends and equipment data. - Lead or assist in troubleshooting and repairing equipment, systems, conveyors, and fixtures to support production uptime. - Provide hands-on training, coaching, and mentorship to maintenance technicians to promote skill development, safety, and accountability. - Ensure shift maintenance reports are completed accurately and submitted on time; clearly communicate equipment issues, status updates, and follow-up actions to other shifts and leadership. - Support installation, commissioning, and training for new equipment and machinery. - Partner with production teams to resolve mechanical issues during operations and ensure efficient start-ups, changeovers, and shutdowns. Secondary Duties: - Serve as point of contact for escalation of maintenance issues during the shift and communicate critical equipment failures or delays to leadership promptly. - Assist and coordinate with external vendors and contractors performing on-site repairs or services. - Participate in continuous improvement initiatives, including root cause analysis and reliability enhancements across departments. - Monitor compliance with safety protocols, department procedures, and GMP requirements; model appropriate use of PPE and safe practices. - Maintain cleanliness and organization of maintenance areas, tools, and parts storage. Collaboration: - Work directly with machine operators and production supervisors to resolve mechanical issues. - Coordinate with other departments on quality, safety, and process improvement efforts. - Communicate clearly with all team members and leadership on maintenance activities and status. Compliance:- - Ensure adherence to Bakerly's safety policies and procedures, including the use of PPE - Follow and enforce all Good Manufacturing Practices (GMPs) and departmental procedures. Supervisory Responsibilities - This role directly supervises the maintenance technician team, including task assignment, performance monitoring, and development. Requirements: Required Qualifications Education: - High school diploma or equivalent; education in Electrical/Mechanical Technology or Industrial Maintenance required. Experience: - Minimum of 2 years in a manufacturing maintenance supervisory role. - Minimum of 2 years of hands-on industrial/mechanical maintenance experience. Skills: - Strong troubleshooting and root cause analysis skills. - Ability to lift 50 pounds and work in variable temperature environments. - Proficient in Microsoft Office (Word, Excel, PowerPoint); familiarity with CMMS and AutoCAD is a plus. - Excellent communication, leadership, and team collaboration skills. Preferred Qualifications - Additional certifications in industrial electricity, automation, or mechanical systems. - Experience with AutoCAD and maintenance software platforms. Physical Requirements - Ability to stoop, kneel, crouch, crawl, or climb (including stairs/ladders). - Ability to stand, walk, and reach with hands and arms. - Ability to lift and/or move up to 50 pounds. - Physical dexterity necessary to handle supplies, machine parts and tools. - Vision abilities: close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment - The role is based on the production floor, which may include exposure to varying temperatures, humidity, and noise levels. - Work involves standing for extended periods and frequent movement, including walking and bending. - Employees may handle or be in proximity to food ingredients, including allergens (e.g., wheat, dairy). - Personal Protective Equipment (PPE) is required at all times, including hairnets, beard nets (if applicable), gloves, and safety shoes. - The environment requires adherence to strict sanitation and safety standards. Location: Easton, Pa Benefits and Perks: - Competitive salary and performance-based bonus incentives. - Comprehensive health, dental, and vision insurance packages. - Employer-paid life insurance and long-term disability - Flexible spending accounts (FSA). - Additional supplemental insurance program offered, including life, critical, accidental, STD - Free stress-management counseling and discounts on health and fitness products. - Generous PTO policy and 401k plan with a 3% employer match. - 9 paid company holidays - 40% discount on all company products. We are committed to ensuring a diverse and inclusive workplace, free from discrimination. Our recruitment process is based solely on individual qualifications and skills, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We adhere to all applicable laws and regulations regarding non-discrimination in employment. PIc2a74c7c180c-6453
07/14/2025
Full time
Description: About our company: Bakerly, a happy family-owned company, is proud to be home to one of the fastest-growing brands in the US food industry! We are a baked goods manufacturer that emphasizes delicious, premium, and authentic recipes using only the very best ingredients. Our offices located in Miami, FL, Easton, PA, and San Antonio, TX, will make you feel right at home. Please visit our website to learn more about our delicious French crêpes, golden chocolate croissants, fluffy pancakes, and our large range of outstanding French brioches. Job Description: Scope/Purpose of the Position The purpose of this position is to lead and support the maintenance team in ensuring optimal functionality of all production, packaging, and warehouse equipment. This role encompasses daily supervision of maintenance technicians, execution of preventive maintenance programs, training initiatives, and continuous improvement efforts, contributing to equipment reliability, production efficiency, and adherence to safety and GMP standards in a high-speed manufacturing environment. This position is for Second Shift with the hours of 2pm - 10pm. Key Responsibilities and Essential Functions Primary Duties: - Assign and manage daily work orders and tasks for maintenance technicians; ensure adequate shift coverage and follow-up on progress throughout the shift. - Oversee execution and continuous improvement of the preventive maintenance program; audit completed work and recommend updates based on failure trends and equipment data. - Lead or assist in troubleshooting and repairing equipment, systems, conveyors, and fixtures to support production uptime. - Provide hands-on training, coaching, and mentorship to maintenance technicians to promote skill development, safety, and accountability. - Ensure shift maintenance reports are completed accurately and submitted on time; clearly communicate equipment issues, status updates, and follow-up actions to other shifts and leadership. - Support installation, commissioning, and training for new equipment and machinery. - Partner with production teams to resolve mechanical issues during operations and ensure efficient start-ups, changeovers, and shutdowns. Secondary Duties: - Serve as point of contact for escalation of maintenance issues during the shift and communicate critical equipment failures or delays to leadership promptly. - Assist and coordinate with external vendors and contractors performing on-site repairs or services. - Participate in continuous improvement initiatives, including root cause analysis and reliability enhancements across departments. - Monitor compliance with safety protocols, department procedures, and GMP requirements; model appropriate use of PPE and safe practices. - Maintain cleanliness and organization of maintenance areas, tools, and parts storage. Collaboration: - Work directly with machine operators and production supervisors to resolve mechanical issues. - Coordinate with other departments on quality, safety, and process improvement efforts. - Communicate clearly with all team members and leadership on maintenance activities and status. Compliance:- - Ensure adherence to Bakerly's safety policies and procedures, including the use of PPE - Follow and enforce all Good Manufacturing Practices (GMPs) and departmental procedures. Supervisory Responsibilities - This role directly supervises the maintenance technician team, including task assignment, performance monitoring, and development. Requirements: Required Qualifications Education: - High school diploma or equivalent; education in Electrical/Mechanical Technology or Industrial Maintenance required. Experience: - Minimum of 2 years in a manufacturing maintenance supervisory role. - Minimum of 2 years of hands-on industrial/mechanical maintenance experience. Skills: - Strong troubleshooting and root cause analysis skills. - Ability to lift 50 pounds and work in variable temperature environments. - Proficient in Microsoft Office (Word, Excel, PowerPoint); familiarity with CMMS and AutoCAD is a plus. - Excellent communication, leadership, and team collaboration skills. Preferred Qualifications - Additional certifications in industrial electricity, automation, or mechanical systems. - Experience with AutoCAD and maintenance software platforms. Physical Requirements - Ability to stoop, kneel, crouch, crawl, or climb (including stairs/ladders). - Ability to stand, walk, and reach with hands and arms. - Ability to lift and/or move up to 50 pounds. - Physical dexterity necessary to handle supplies, machine parts and tools. - Vision abilities: close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment - The role is based on the production floor, which may include exposure to varying temperatures, humidity, and noise levels. - Work involves standing for extended periods and frequent movement, including walking and bending. - Employees may handle or be in proximity to food ingredients, including allergens (e.g., wheat, dairy). - Personal Protective Equipment (PPE) is required at all times, including hairnets, beard nets (if applicable), gloves, and safety shoes. - The environment requires adherence to strict sanitation and safety standards. Location: Easton, Pa Benefits and Perks: - Competitive salary and performance-based bonus incentives. - Comprehensive health, dental, and vision insurance packages. - Employer-paid life insurance and long-term disability - Flexible spending accounts (FSA). - Additional supplemental insurance program offered, including life, critical, accidental, STD - Free stress-management counseling and discounts on health and fitness products. - Generous PTO policy and 401k plan with a 3% employer match. - 9 paid company holidays - 40% discount on all company products. We are committed to ensuring a diverse and inclusive workplace, free from discrimination. Our recruitment process is based solely on individual qualifications and skills, without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We adhere to all applicable laws and regulations regarding non-discrimination in employment. PIc2a74c7c180c-6453
$2500 SIGN ON BONUS! (Not applicable for Internal Employees) WHO WE ARE AND WHAT WE DO: At Corteva Agriscience, you will help us grow what is next! No matter your role, you will be part of a team that is building the future of agriculture - leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind. We have anexciting opportunity for a Maintenance Electrician to join our team at our Princeton, Illinois location! WHAT YOU WILL DO: Perform a variety of tasks to support general plant operations and field activities that will evolve with each season throughout the year responsible for completion of PM's as well as preseason projects linked to our RTO Support Plant Operations Deliver maintenance support for Capital projects Maintain Condition of the plant shop and maintenance tools Support Process Safety Management and location safety efforts Conduct seasonal prep work including Annual Preventative Maintenance, Repairs, and Improvements Assure proper set-up, calibration, operation, and preventative maintenance of equipment, machines, and facilities Complete grounds and facility maintenance as needed Utilize Predictive Maintenance tools to detect and remedy future machine failures. Create, continually update, and train Preventative Maintenance plans for varied equipment Complete fabrication projects to improve plant processes Maintain detailed equipment records and prints Various other duties as assigned EDUCATION: You have your High School Diploma or equivalent WHAT SKILLS YOU NEED: You have a minimum of two (2) years of industrial maintenance or other related experience You possess working knowledge and are willing and able to interpret the National Electric Code (NEC) You are willing and able to do the following with or without reasonable accommodation: Climb and/or work in elevated areas, Stand and sit for extended periods, work outdoors and indoors in hot, cold, wet, and dry conditions, lift up to fifty (50) lbs., and perform work that involves repetitive motion and lifting You are comfortable with technology and possess good computer aptitude including the use of Microsoft Applications (Outlook, Word, Excel, PowerPoint, etc.), and are willing and able to learn other company specific applications as required You have high attention to detail can multitask, maintain an organized workplace and excellent problem-solving skills You have good written, verbal, and interpersonal communication skills with the ability to communicate effectively with internal and external customers You have a valid US Driver's License You demonstrate integrity and promote a positive working environment by being a self-starter and willing to assist team members on a consist basis Maintain detailed equipment records and prints You uphold health and safety to the highest standard! You consistently help others and demonstrate adherence to safety protocols, policies, and procedures to ensure you and your colleagues go home safely every day You understand that delivering to our customers on time keeps us viable and are willing and able to work a rotating shift and overtime hours, which can include nights and weekends during seasonal peaks to support production demand WHAT MAKES YOU STAND OUT: Two-Year Technical or Associates Degree in Maintenance, Electrical, Agriculture, Manufacturing, or related field Programmable Logic Controls (PLC) and/or Automation knowledge or experience Additional industrial maintenance work experience (to include production equipment - electrical, mechanical, hydraulics, instrumentation and controls, and general maintenance experience) WORK AUTHORIZATION AND RELOCATION: VISA Sponsorship is NOT available for this position This position does NOT offer a comprehensive domestic relocation package SITE DEDICATED (100% at Corteva location): This role will be on-site at our Corteva location The salary range for this position is $56,780 to $70,970 Benefits - How We'll Support You: Numerous development opportunities offered to build your skills Be part of a company with a higher purpose and contribute to making the world a better place Health benefits for you and your family on your first day of employment Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays Excellent parental leave which includes a minimum of 16 weeks for mother and father Future planning with our competitive retirement savings plan and tuition reimbursement program Learn more about our total rewards package here - Corteva Benefits Check out life at Corteva! Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. The salary range for this position is $56,780.00 to $70,970.00. This reflects a reasonable estimate of the targeted base salary for this role. This role is also eligible for an annual bonus. Based on factors such as geographic location and candidate qualifications, actual base pay is determined when an employment offer is made. Corteva Agriscience is an equal opportunity employer. We are committed to embracing our differences to enrich lives, advance innovation, and boost company performance. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, military or veteran status, pregnancy related conditions (including pregnancy, childbirth, or related medical conditions), disability or any other protected status in accordance with federal, state, or local laws.
07/11/2025
Full time
$2500 SIGN ON BONUS! (Not applicable for Internal Employees) WHO WE ARE AND WHAT WE DO: At Corteva Agriscience, you will help us grow what is next! No matter your role, you will be part of a team that is building the future of agriculture - leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind. We have anexciting opportunity for a Maintenance Electrician to join our team at our Princeton, Illinois location! WHAT YOU WILL DO: Perform a variety of tasks to support general plant operations and field activities that will evolve with each season throughout the year responsible for completion of PM's as well as preseason projects linked to our RTO Support Plant Operations Deliver maintenance support for Capital projects Maintain Condition of the plant shop and maintenance tools Support Process Safety Management and location safety efforts Conduct seasonal prep work including Annual Preventative Maintenance, Repairs, and Improvements Assure proper set-up, calibration, operation, and preventative maintenance of equipment, machines, and facilities Complete grounds and facility maintenance as needed Utilize Predictive Maintenance tools to detect and remedy future machine failures. Create, continually update, and train Preventative Maintenance plans for varied equipment Complete fabrication projects to improve plant processes Maintain detailed equipment records and prints Various other duties as assigned EDUCATION: You have your High School Diploma or equivalent WHAT SKILLS YOU NEED: You have a minimum of two (2) years of industrial maintenance or other related experience You possess working knowledge and are willing and able to interpret the National Electric Code (NEC) You are willing and able to do the following with or without reasonable accommodation: Climb and/or work in elevated areas, Stand and sit for extended periods, work outdoors and indoors in hot, cold, wet, and dry conditions, lift up to fifty (50) lbs., and perform work that involves repetitive motion and lifting You are comfortable with technology and possess good computer aptitude including the use of Microsoft Applications (Outlook, Word, Excel, PowerPoint, etc.), and are willing and able to learn other company specific applications as required You have high attention to detail can multitask, maintain an organized workplace and excellent problem-solving skills You have good written, verbal, and interpersonal communication skills with the ability to communicate effectively with internal and external customers You have a valid US Driver's License You demonstrate integrity and promote a positive working environment by being a self-starter and willing to assist team members on a consist basis Maintain detailed equipment records and prints You uphold health and safety to the highest standard! You consistently help others and demonstrate adherence to safety protocols, policies, and procedures to ensure you and your colleagues go home safely every day You understand that delivering to our customers on time keeps us viable and are willing and able to work a rotating shift and overtime hours, which can include nights and weekends during seasonal peaks to support production demand WHAT MAKES YOU STAND OUT: Two-Year Technical or Associates Degree in Maintenance, Electrical, Agriculture, Manufacturing, or related field Programmable Logic Controls (PLC) and/or Automation knowledge or experience Additional industrial maintenance work experience (to include production equipment - electrical, mechanical, hydraulics, instrumentation and controls, and general maintenance experience) WORK AUTHORIZATION AND RELOCATION: VISA Sponsorship is NOT available for this position This position does NOT offer a comprehensive domestic relocation package SITE DEDICATED (100% at Corteva location): This role will be on-site at our Corteva location The salary range for this position is $56,780 to $70,970 Benefits - How We'll Support You: Numerous development opportunities offered to build your skills Be part of a company with a higher purpose and contribute to making the world a better place Health benefits for you and your family on your first day of employment Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays Excellent parental leave which includes a minimum of 16 weeks for mother and father Future planning with our competitive retirement savings plan and tuition reimbursement program Learn more about our total rewards package here - Corteva Benefits Check out life at Corteva! Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. The salary range for this position is $56,780.00 to $70,970.00. This reflects a reasonable estimate of the targeted base salary for this role. This role is also eligible for an annual bonus. Based on factors such as geographic location and candidate qualifications, actual base pay is determined when an employment offer is made. Corteva Agriscience is an equal opportunity employer. We are committed to embracing our differences to enrich lives, advance innovation, and boost company performance. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, military or veteran status, pregnancy related conditions (including pregnancy, childbirth, or related medical conditions), disability or any other protected status in accordance with federal, state, or local laws.
$2500 SIGN ON BONUS! (Not applicable for Internal Employees) WHO WE ARE AND WHAT WE DO: At Corteva Agriscience, you will help us grow what is next! No matter your role, you will be part of a team that is building the future of agriculture - leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind. We have anexciting opportunity for a Maintenance Electrician to join our team at our Princeton, Illinois location! WHAT YOU WILL DO: Perform a variety of tasks to support general plant operations and field activities that will evolve with each season throughout the year responsible for completion of PM's as well as preseason projects linked to our RTO Support Plant Operations Deliver maintenance support for Capital projects Maintain Condition of the plant shop and maintenance tools Support Process Safety Management and location safety efforts Conduct seasonal prep work including Annual Preventative Maintenance, Repairs, and Improvements Assure proper set-up, calibration, operation, and preventative maintenance of equipment, machines, and facilities Complete grounds and facility maintenance as needed Utilize Predictive Maintenance tools to detect and remedy future machine failures. Create, continually update, and train Preventative Maintenance plans for varied equipment Complete fabrication projects to improve plant processes Maintain detailed equipment records and prints Various other duties as assigned EDUCATION: You have your High School Diploma or equivalent WHAT SKILLS YOU NEED: You have a minimum of two (2) years of industrial maintenance or other related experience You possess working knowledge and are willing and able to interpret the National Electric Code (NEC) You are willing and able to do the following with or without reasonable accommodation: Climb and/or work in elevated areas, Stand and sit for extended periods, work outdoors and indoors in hot, cold, wet, and dry conditions, lift up to fifty (50) lbs., and perform work that involves repetitive motion and lifting You are comfortable with technology and possess good computer aptitude including the use of Microsoft Applications (Outlook, Word, Excel, PowerPoint, etc.), and are willing and able to learn other company specific applications as required You have high attention to detail can multitask, maintain an organized workplace and excellent problem-solving skills You have good written, verbal, and interpersonal communication skills with the ability to communicate effectively with internal and external customers You have a valid US Driver's License You demonstrate integrity and promote a positive working environment by being a self-starter and willing to assist team members on a consist basis Maintain detailed equipment records and prints You uphold health and safety to the highest standard! You consistently help others and demonstrate adherence to safety protocols, policies, and procedures to ensure you and your colleagues go home safely every day You understand that delivering to our customers on time keeps us viable and are willing and able to work a rotating shift and overtime hours, which can include nights and weekends during seasonal peaks to support production demand WHAT MAKES YOU STAND OUT: Two-Year Technical or Associates Degree in Maintenance, Electrical, Agriculture, Manufacturing, or related field Programmable Logic Controls (PLC) and/or Automation knowledge or experience Additional industrial maintenance work experience (to include production equipment - electrical, mechanical, hydraulics, instrumentation and controls, and general maintenance experience) WORK AUTHORIZATION AND RELOCATION: VISA Sponsorship is NOT available for this position This position does NOT offer a comprehensive domestic relocation package SITE DEDICATED (100% at Corteva location): This role will be on-site at our Corteva location The salary range for this position is $56,780 to $70,970 Benefits - How We'll Support You: Numerous development opportunities offered to build your skills Be part of a company with a higher purpose and contribute to making the world a better place Health benefits for you and your family on your first day of employment Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays Excellent parental leave which includes a minimum of 16 weeks for mother and father Future planning with our competitive retirement savings plan and tuition reimbursement program Learn more about our total rewards package here - Corteva Benefits Check out life at Corteva! Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. The salary range for this position is $56,780.00 to $70,970.00. This reflects a reasonable estimate of the targeted base salary for this role. This role is also eligible for an annual bonus. Based on factors such as geographic location and candidate qualifications, actual base pay is determined when an employment offer is made. Corteva Agriscience is an equal opportunity employer. We are committed to embracing our differences to enrich lives, advance innovation, and boost company performance. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, military or veteran status, pregnancy related conditions (including pregnancy, childbirth, or related medical conditions), disability or any other protected status in accordance with federal, state, or local laws.
07/01/2025
Full time
$2500 SIGN ON BONUS! (Not applicable for Internal Employees) WHO WE ARE AND WHAT WE DO: At Corteva Agriscience, you will help us grow what is next! No matter your role, you will be part of a team that is building the future of agriculture - leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind. We have anexciting opportunity for a Maintenance Electrician to join our team at our Princeton, Illinois location! WHAT YOU WILL DO: Perform a variety of tasks to support general plant operations and field activities that will evolve with each season throughout the year responsible for completion of PM's as well as preseason projects linked to our RTO Support Plant Operations Deliver maintenance support for Capital projects Maintain Condition of the plant shop and maintenance tools Support Process Safety Management and location safety efforts Conduct seasonal prep work including Annual Preventative Maintenance, Repairs, and Improvements Assure proper set-up, calibration, operation, and preventative maintenance of equipment, machines, and facilities Complete grounds and facility maintenance as needed Utilize Predictive Maintenance tools to detect and remedy future machine failures. Create, continually update, and train Preventative Maintenance plans for varied equipment Complete fabrication projects to improve plant processes Maintain detailed equipment records and prints Various other duties as assigned EDUCATION: You have your High School Diploma or equivalent WHAT SKILLS YOU NEED: You have a minimum of two (2) years of industrial maintenance or other related experience You possess working knowledge and are willing and able to interpret the National Electric Code (NEC) You are willing and able to do the following with or without reasonable accommodation: Climb and/or work in elevated areas, Stand and sit for extended periods, work outdoors and indoors in hot, cold, wet, and dry conditions, lift up to fifty (50) lbs., and perform work that involves repetitive motion and lifting You are comfortable with technology and possess good computer aptitude including the use of Microsoft Applications (Outlook, Word, Excel, PowerPoint, etc.), and are willing and able to learn other company specific applications as required You have high attention to detail can multitask, maintain an organized workplace and excellent problem-solving skills You have good written, verbal, and interpersonal communication skills with the ability to communicate effectively with internal and external customers You have a valid US Driver's License You demonstrate integrity and promote a positive working environment by being a self-starter and willing to assist team members on a consist basis Maintain detailed equipment records and prints You uphold health and safety to the highest standard! You consistently help others and demonstrate adherence to safety protocols, policies, and procedures to ensure you and your colleagues go home safely every day You understand that delivering to our customers on time keeps us viable and are willing and able to work a rotating shift and overtime hours, which can include nights and weekends during seasonal peaks to support production demand WHAT MAKES YOU STAND OUT: Two-Year Technical or Associates Degree in Maintenance, Electrical, Agriculture, Manufacturing, or related field Programmable Logic Controls (PLC) and/or Automation knowledge or experience Additional industrial maintenance work experience (to include production equipment - electrical, mechanical, hydraulics, instrumentation and controls, and general maintenance experience) WORK AUTHORIZATION AND RELOCATION: VISA Sponsorship is NOT available for this position This position does NOT offer a comprehensive domestic relocation package SITE DEDICATED (100% at Corteva location): This role will be on-site at our Corteva location The salary range for this position is $56,780 to $70,970 Benefits - How We'll Support You: Numerous development opportunities offered to build your skills Be part of a company with a higher purpose and contribute to making the world a better place Health benefits for you and your family on your first day of employment Four weeks of paid time off and two weeks of well-being pay per year, plus paid holidays Excellent parental leave which includes a minimum of 16 weeks for mother and father Future planning with our competitive retirement savings plan and tuition reimbursement program Learn more about our total rewards package here - Corteva Benefits Check out life at Corteva! Are you a good match? Apply today! We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. The salary range for this position is $56,780.00 to $70,970.00. This reflects a reasonable estimate of the targeted base salary for this role. This role is also eligible for an annual bonus. Based on factors such as geographic location and candidate qualifications, actual base pay is determined when an employment offer is made. Corteva Agriscience is an equal opportunity employer. We are committed to embracing our differences to enrich lives, advance innovation, and boost company performance. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, military or veteran status, pregnancy related conditions (including pregnancy, childbirth, or related medical conditions), disability or any other protected status in accordance with federal, state, or local laws.
BHS Corrugated North America is seeking skilled Electrical Field Service Engineers with a background in Industrial Maintenance and controls. The Job: As an Electrical Field Service Engineer with BHS, your primary responsibility will be the trouble shooting and repair of corrugated machinery at our customer sites. You will do this by: Traveling close to 100% of the time to provide service to customers throughout North America Performing electrical maintenance tasks Performing system upgrades and inspections Performing trouble shooting and warranty service interventions Providing occasional on-call emergency support to our customer base. Your job will be based all over North America as you will be traveling to provide service to our customers in the United States, Canada and Mexico. BHS has offices in Baltimore, MD and Knoxville, TN, but we have team members who represent us in 19 states. You will be joining a knowledgeable and passionate team of more than 30 other field service specialists! If you have Electrical Industrial Maintenance experience with strong automation control skills and are looking for a company to grow your knowledge and skills with, then this is the job for you! The Fit: To fit in with us, you will need to have a fascination with the inner workings of machines, who won???t stop until the job is done. You will be incredibly eager, always ready to learn additional information about the evolving and complex corrugated industry. You???ll be industrious and results oriented, where you want to be measured based on your output and successful completion of jobs. The Experience: 5-10 years of previous experience in the field of Industrial Maintenance performing electrical work with strong trouble shooting skills is a must! Experience in the corrugated industry, or a basic knowledge of corrugated equipment is a bonus, but not required. Other areas of experience that we are seeking, include: Experience with PLC controls and programming; STL & SCL required Experience working with hydraulics and pneumatics Ability to read electrical schematics. Ability to stand, walk, reach, bend or lift up to 50 pounds an A.A., bachelor, or technical/trade school certificate is preferred. The Salary: Salary is based on experience, but with evening, weekend, and overtime hours, your pay is determined by you and your availability as opportunities for overtime are always available! Your benefits will include health, dental and vision insurance, vacation time, personal/sick time and company paid benefits including: life insurance, short-term disability, and long-term disability. BHS also offers a 401k match and tuition reimbursement! About BHS: BHS is the world???s largest provider of solutions for the corrugated industry. We are a privately-owned company, headquartered out of Germany, with more than 50 years in the corrugated industry. BHS has had a presence in North America for 25 years, primarily focusing on sales and service of corrugated equipment.
09/23/2021
Full time
BHS Corrugated North America is seeking skilled Electrical Field Service Engineers with a background in Industrial Maintenance and controls. The Job: As an Electrical Field Service Engineer with BHS, your primary responsibility will be the trouble shooting and repair of corrugated machinery at our customer sites. You will do this by: Traveling close to 100% of the time to provide service to customers throughout North America Performing electrical maintenance tasks Performing system upgrades and inspections Performing trouble shooting and warranty service interventions Providing occasional on-call emergency support to our customer base. Your job will be based all over North America as you will be traveling to provide service to our customers in the United States, Canada and Mexico. BHS has offices in Baltimore, MD and Knoxville, TN, but we have team members who represent us in 19 states. You will be joining a knowledgeable and passionate team of more than 30 other field service specialists! If you have Electrical Industrial Maintenance experience with strong automation control skills and are looking for a company to grow your knowledge and skills with, then this is the job for you! The Fit: To fit in with us, you will need to have a fascination with the inner workings of machines, who won???t stop until the job is done. You will be incredibly eager, always ready to learn additional information about the evolving and complex corrugated industry. You???ll be industrious and results oriented, where you want to be measured based on your output and successful completion of jobs. The Experience: 5-10 years of previous experience in the field of Industrial Maintenance performing electrical work with strong trouble shooting skills is a must! Experience in the corrugated industry, or a basic knowledge of corrugated equipment is a bonus, but not required. Other areas of experience that we are seeking, include: Experience with PLC controls and programming; STL & SCL required Experience working with hydraulics and pneumatics Ability to read electrical schematics. Ability to stand, walk, reach, bend or lift up to 50 pounds an A.A., bachelor, or technical/trade school certificate is preferred. The Salary: Salary is based on experience, but with evening, weekend, and overtime hours, your pay is determined by you and your availability as opportunities for overtime are always available! Your benefits will include health, dental and vision insurance, vacation time, personal/sick time and company paid benefits including: life insurance, short-term disability, and long-term disability. BHS also offers a 401k match and tuition reimbursement! About BHS: BHS is the world???s largest provider of solutions for the corrugated industry. We are a privately-owned company, headquartered out of Germany, with more than 50 years in the corrugated industry. BHS has had a presence in North America for 25 years, primarily focusing on sales and service of corrugated equipment.
East Carolina University
Greenville, North Carolina
East Carolina University Building Automation Systems/Controls Technician for HVAC Vacancy #: 903855 Anticipated Hiring Range: $39,558 - $59,020 Closing Date: 09/23/2021 Organizational Unit Overview Facilities Services is a unit in Campus Operations Division, which is a part of a broad, diverse division of Administration and Finance that includes all aspects of facilities management at East Carolina University. East Carolina University is the third largest university in the University of North Carolina system with approximately 28,000 FTS and a staff of over 6,000. The university is comprised of more than 7 million square feet of facilities located on approximately 1,400 acres with physical assets in excess of $1.5 billion. This includes the Main, Health Sciences, and West Research Campuses, and satellite locations throughout North Carolina associated with university programs. Facilities Services has an annual budget in excess of $30 million and employs approximately 500 FTE. Major functions include facilities maintenance and housekeeping services. Facilities Service's primary purpose is to plan and perform corrective and preventive maintenance functions on all building structures and equipment and utility infrastructure. Corrective maintenance returns equipment to optimal design performance after failure or upon degradation from age, adverse operation conditions, etc. Preventive maintenance minimizes equipment failures and reduces corrective maintenance. Job Duties This position is for Main Campus HVAC Building Automation Systems (BAS) and other Controls Systems. ECU is seeking a Technician with relative experience to routinely and consistently perform a variety of work on the Supervisory Controls and Data Acquisition (SCADA) systems will be functionally at the building level and below. Work will also involve the support of higher-level technicians in the installation and maintenance of complex enterprise-level SCADA systems. This involves highly technical work in the installation, set-up, commissioning, troubleshooting, and maintenance of moderately complex building systems level controls (i.e., Field Controller Networks (FCN), Air handling units (AHU's), terminal units Variable air volume (VAV) and Constant air volume (CAV), exhaust fans, chillers, boilers, pumps, compressors, energy recover units, etc. and industrial instrumentation installation and calibration. The Energy Utilities Specialist will independently investigate and analyze Building Level Network (BLN) controls systems components, recommend changes, implement repairs as directed and verify results. The Energy Utilities Specialist will: verify that BLN operations are consistent with SOPs; troubleshoot and resolve inconsistencies in the field controller settings or sequence of operations; and work with higher level technicians for technical support as/when needed. The Energy Utilities Specialist run reports to analyze equipment operation and efficiency (i.e., PID loops, instrument calibration, building schedules, etc.); participate in inspections and testing on new equipment. They often serve as a technical resource in one or more areas of HVAC, SCADA Systems, or industrial instrumentation. Energy Utilities Specialist work with contractors to support equipment startup services; work with ECU IT Department personnel; work with other department technicians to complete facilities services projects. The Energy Utilities Specialist will prioritize work assignments to ensure work is completed in a timely and efficient manner, taking into consideration the potential impact to both operations and regulatory requirements. Energy Utilities Specialist must also be a member of a team of skilled trade's people. Work is performed under the general supervision of the controls department supervisor or a higher technician and is evaluated through the optimization of building controls, equipment operation, project completion, and the effectiveness of repairs. The Energy Utilities Specialist will perform both preventative and corrective maintenance work orders. Minimum Education/Experience High School diploma or equivalency and two years of related experience; or equivalent combination of training and experience. Requires certification(s). Preferred Experience, Skills, Training/Education Associate's Degree or equivalent from a two-year college or technical school in HVAC, Computer Science, Industrial Instrumentation/Electronics or controls related field. At least two years of progressive experience as a HVAC Controls or Instrumentation and Controls (I&C) technician is preferred. Understanding of the basic refrigeration process used in mechanical refrigeration and air conditioning systems; to include terminology, safety, and identification and function of components; refrigeration cycle; and tools and instrumentation used in mechanical refrigeration is advantageous. A strong working- knowledge of Microsoft Products and computers as well as knowledge and understanding of any of the following areas will be advantageous: various communications protocols used in the industry including ACnet, LonTalk and Modbus; familiarity with networking applications; familiarity with SCADA systems; Ethernet, TCP-IP, IP Networks and infrastructure. Experience with Carrier-IVue, Trane, Tridium, Johnson Controls. Schneider, or Siemens is preferred. Applicants holding a NICET Industrial Instrumentation Level I Certification are preferred. License or Certification required by the Department Current certification by EPA as a Type: I, II, III or universal technician as required by CFR 40 Part 82, Subpart E. A valid NC driver's license and satisfactory driving-record. Special Instructions to Applicant Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write 'see resume' on your application when completing the job duties section. If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment). Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities. Applicants must be currently authorized to work in the United States on a full-time basis. Application Types Accepted Applications must be received in the Department of Human Resources by the closing date of 09/23/2021 to be considered. Please submit an online ECU application for vacancy # 903855 to ECU Human Resources at . East Carolina University is an Equal Opportunity/Affirmative Action Employer. Visit this job posting at recblid 1y1kils9tuqzjhqswt7c27r15fmbcm
09/22/2021
Full time
East Carolina University Building Automation Systems/Controls Technician for HVAC Vacancy #: 903855 Anticipated Hiring Range: $39,558 - $59,020 Closing Date: 09/23/2021 Organizational Unit Overview Facilities Services is a unit in Campus Operations Division, which is a part of a broad, diverse division of Administration and Finance that includes all aspects of facilities management at East Carolina University. East Carolina University is the third largest university in the University of North Carolina system with approximately 28,000 FTS and a staff of over 6,000. The university is comprised of more than 7 million square feet of facilities located on approximately 1,400 acres with physical assets in excess of $1.5 billion. This includes the Main, Health Sciences, and West Research Campuses, and satellite locations throughout North Carolina associated with university programs. Facilities Services has an annual budget in excess of $30 million and employs approximately 500 FTE. Major functions include facilities maintenance and housekeeping services. Facilities Service's primary purpose is to plan and perform corrective and preventive maintenance functions on all building structures and equipment and utility infrastructure. Corrective maintenance returns equipment to optimal design performance after failure or upon degradation from age, adverse operation conditions, etc. Preventive maintenance minimizes equipment failures and reduces corrective maintenance. Job Duties This position is for Main Campus HVAC Building Automation Systems (BAS) and other Controls Systems. ECU is seeking a Technician with relative experience to routinely and consistently perform a variety of work on the Supervisory Controls and Data Acquisition (SCADA) systems will be functionally at the building level and below. Work will also involve the support of higher-level technicians in the installation and maintenance of complex enterprise-level SCADA systems. This involves highly technical work in the installation, set-up, commissioning, troubleshooting, and maintenance of moderately complex building systems level controls (i.e., Field Controller Networks (FCN), Air handling units (AHU's), terminal units Variable air volume (VAV) and Constant air volume (CAV), exhaust fans, chillers, boilers, pumps, compressors, energy recover units, etc. and industrial instrumentation installation and calibration. The Energy Utilities Specialist will independently investigate and analyze Building Level Network (BLN) controls systems components, recommend changes, implement repairs as directed and verify results. The Energy Utilities Specialist will: verify that BLN operations are consistent with SOPs; troubleshoot and resolve inconsistencies in the field controller settings or sequence of operations; and work with higher level technicians for technical support as/when needed. The Energy Utilities Specialist run reports to analyze equipment operation and efficiency (i.e., PID loops, instrument calibration, building schedules, etc.); participate in inspections and testing on new equipment. They often serve as a technical resource in one or more areas of HVAC, SCADA Systems, or industrial instrumentation. Energy Utilities Specialist work with contractors to support equipment startup services; work with ECU IT Department personnel; work with other department technicians to complete facilities services projects. The Energy Utilities Specialist will prioritize work assignments to ensure work is completed in a timely and efficient manner, taking into consideration the potential impact to both operations and regulatory requirements. Energy Utilities Specialist must also be a member of a team of skilled trade's people. Work is performed under the general supervision of the controls department supervisor or a higher technician and is evaluated through the optimization of building controls, equipment operation, project completion, and the effectiveness of repairs. The Energy Utilities Specialist will perform both preventative and corrective maintenance work orders. Minimum Education/Experience High School diploma or equivalency and two years of related experience; or equivalent combination of training and experience. Requires certification(s). Preferred Experience, Skills, Training/Education Associate's Degree or equivalent from a two-year college or technical school in HVAC, Computer Science, Industrial Instrumentation/Electronics or controls related field. At least two years of progressive experience as a HVAC Controls or Instrumentation and Controls (I&C) technician is preferred. Understanding of the basic refrigeration process used in mechanical refrigeration and air conditioning systems; to include terminology, safety, and identification and function of components; refrigeration cycle; and tools and instrumentation used in mechanical refrigeration is advantageous. A strong working- knowledge of Microsoft Products and computers as well as knowledge and understanding of any of the following areas will be advantageous: various communications protocols used in the industry including ACnet, LonTalk and Modbus; familiarity with networking applications; familiarity with SCADA systems; Ethernet, TCP-IP, IP Networks and infrastructure. Experience with Carrier-IVue, Trane, Tridium, Johnson Controls. Schneider, or Siemens is preferred. Applicants holding a NICET Industrial Instrumentation Level I Certification are preferred. License or Certification required by the Department Current certification by EPA as a Type: I, II, III or universal technician as required by CFR 40 Part 82, Subpart E. A valid NC driver's license and satisfactory driving-record. Special Instructions to Applicant Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write 'see resume' on your application when completing the job duties section. If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment). Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities. Applicants must be currently authorized to work in the United States on a full-time basis. Application Types Accepted Applications must be received in the Department of Human Resources by the closing date of 09/23/2021 to be considered. Please submit an online ECU application for vacancy # 903855 to ECU Human Resources at . East Carolina University is an Equal Opportunity/Affirmative Action Employer. Visit this job posting at recblid 1y1kils9tuqzjhqswt7c27r15fmbcm
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Purpose: Reporting to a Maintenance Manager / Supervisor, incumbent will be responsible for the maintenance of aseptic and non-aseptic process equipment (GMP & non-GMP) in the Bulk and Fill Finish, Packaging, labeling, and cartoning areas. Incumbent will engage in supporting manufacturing and the execution of maintenance tasks, with minimal supervision. Shift - Nights Hours- 6PM-6AM Follows the 2,2, 3 schedule - off every other weekend Level will be determined based on years of experience Major Accountabilities: Works closely with Quality, Engineering and Operations groups to ensure strict compliance with GMP guidelines at all times, specifically to ensure that the equipment is maintained in GMP compliance. Maintains and performs corrective, preventative maintenance on aseptic and non-aseptic manufacturing equipment for in GMP & non-GMP systems. Maintains and provides recommendations for spare parts and PM procedures for equipment. Supports other departments/areas to troubleshoot, test, repair, and optimize, equipment. Participates in the continuous improvement efforts within the site Maintenance Program (including reliability). Responsible to respond to alarms for assigned equipment/areas. Executes maintenance work for various customers with minimal interruptions. Works with contract service providers and support contractors executing maintenance activities. Provides support for start-up, commissioning and turnover of new systems in assigned area. Uses tools and software (CMMS, PAS, Pi, PLCs, ETOPS, SAP) required to resolve equipment and process issues within all technical competencies. Assists other technicians and associates. Minimum Requirements: High school diploma or Equivalent required. Minimum of 1 year relevant industry experience or an associate's degree in relevant technical discipline with 2+ years of experience OR equivalent. Strong desire experience with trouble-shooting pharmaceutical manufacturing process problems (e.g., centrifuges, pressure test failures, electrical, autoclaves, utilities, clean steam, filling/packaging) Experience and knowledge of maintenance principles within a cGMP Biotechnology / Pharmaceutical manufacturing environment. Knowledge of DCS, PLC, and/or Building Automation Systems (BAS) control systems. Proven knowledge of a Computerized Maintenance Management System (CMMS). Ability to problem solve and troubleshoot systems in an industrial environment required Ability to plan and organize tasks. Interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
09/09/2021
Full time
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Purpose: Reporting to a Maintenance Manager / Supervisor, incumbent will be responsible for the maintenance of aseptic and non-aseptic process equipment (GMP & non-GMP) in the Bulk and Fill Finish, Packaging, labeling, and cartoning areas. Incumbent will engage in supporting manufacturing and the execution of maintenance tasks, with minimal supervision. Shift - Nights Hours- 6PM-6AM Follows the 2,2, 3 schedule - off every other weekend Level will be determined based on years of experience Major Accountabilities: Works closely with Quality, Engineering and Operations groups to ensure strict compliance with GMP guidelines at all times, specifically to ensure that the equipment is maintained in GMP compliance. Maintains and performs corrective, preventative maintenance on aseptic and non-aseptic manufacturing equipment for in GMP & non-GMP systems. Maintains and provides recommendations for spare parts and PM procedures for equipment. Supports other departments/areas to troubleshoot, test, repair, and optimize, equipment. Participates in the continuous improvement efforts within the site Maintenance Program (including reliability). Responsible to respond to alarms for assigned equipment/areas. Executes maintenance work for various customers with minimal interruptions. Works with contract service providers and support contractors executing maintenance activities. Provides support for start-up, commissioning and turnover of new systems in assigned area. Uses tools and software (CMMS, PAS, Pi, PLCs, ETOPS, SAP) required to resolve equipment and process issues within all technical competencies. Assists other technicians and associates. Minimum Requirements: High school diploma or Equivalent required. Minimum of 1 year relevant industry experience or an associate's degree in relevant technical discipline with 2+ years of experience OR equivalent. Strong desire experience with trouble-shooting pharmaceutical manufacturing process problems (e.g., centrifuges, pressure test failures, electrical, autoclaves, utilities, clean steam, filling/packaging) Experience and knowledge of maintenance principles within a cGMP Biotechnology / Pharmaceutical manufacturing environment. Knowledge of DCS, PLC, and/or Building Automation Systems (BAS) control systems. Proven knowledge of a Computerized Maintenance Management System (CMMS). Ability to problem solve and troubleshoot systems in an industrial environment required Ability to plan and organize tasks. Interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
Position Purpose: The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the electrical system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will support operations, maintenance, manufacturing, automation, quality assurance, EHS, reliability engineering, project delivery and global engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the plant electrical systems. Assist with creating plans, perform equipment selection, load calculations and power system studies. Periodically review and update the Short Circuit Coordination Study. Responsible to support cGMP facility design and improvement projects. Play an essential leadership role in the operation and troubleshooting of the utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Perform regular field walk-through tours, inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Key member of the Energy and Sustainability initiatives. Drive development of the WAGES program. Collect, analyze and report data for use by the Utilities and Operations department. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and support development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the electrical system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating electrical drawings. Support small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Electrical Engineering with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience: Experience working in a Union environment is preferred but not required. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Must be able to read and interpret electrical and control drawings. Extensive knowledge of electrical design standards, IEEE, NFPA requirements and other codes related to design, safety and maintenance. Must have design and working experience with electrical power distribution at 115kV, 15kV and 480v. Must have Building design and commissioning experience. Must have design and working experience for the following types of equipment as a minimum: Generators, Switchgears, UPS, Inverters, Automatic Transfer Switches, Transformers, Harmonic Filters, Variable Frequency Drives, Motor Control Centers (MCC's), Motor Starters, Interior and Exterior Lighting and Power Management System. Experience performing Power Systems Studies using analysis software. (SKM Power Tools Preferred). Experience in electrical and instrumentation design in hazardous locations. Experience in electrical and instrumentation design in ISO clean room locations. Experience in security and access control systems. Experience in fire alarm and smoke control systems. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies: Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness #cslbehring
01/30/2021
Full time
Position Purpose: The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the electrical system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will support operations, maintenance, manufacturing, automation, quality assurance, EHS, reliability engineering, project delivery and global engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the plant electrical systems. Assist with creating plans, perform equipment selection, load calculations and power system studies. Periodically review and update the Short Circuit Coordination Study. Responsible to support cGMP facility design and improvement projects. Play an essential leadership role in the operation and troubleshooting of the utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Perform regular field walk-through tours, inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Key member of the Energy and Sustainability initiatives. Drive development of the WAGES program. Collect, analyze and report data for use by the Utilities and Operations department. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and support development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the electrical system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating electrical drawings. Support small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Electrical Engineering with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience: Experience working in a Union environment is preferred but not required. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Must be able to read and interpret electrical and control drawings. Extensive knowledge of electrical design standards, IEEE, NFPA requirements and other codes related to design, safety and maintenance. Must have design and working experience with electrical power distribution at 115kV, 15kV and 480v. Must have Building design and commissioning experience. Must have design and working experience for the following types of equipment as a minimum: Generators, Switchgears, UPS, Inverters, Automatic Transfer Switches, Transformers, Harmonic Filters, Variable Frequency Drives, Motor Control Centers (MCC's), Motor Starters, Interior and Exterior Lighting and Power Management System. Experience performing Power Systems Studies using analysis software. (SKM Power Tools Preferred). Experience in electrical and instrumentation design in hazardous locations. Experience in electrical and instrumentation design in ISO clean room locations. Experience in security and access control systems. Experience in fire alarm and smoke control systems. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies: Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness #cslbehring
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
01/27/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews. Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment. Responsible for asset lifecycle management Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements Participate and provide support for audits. Lead, participate, and provide subject matter expertise in the design review and selection of new equipment. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements Participate in FAT, Commissioning of new and modified equipment Perform functional equivalency assessment of spare parts. In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment. Participate and provide support for audits. Develop business case for improvements requiring investments and participate in capital planning for assigned area. Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS) Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: • Bachelor's Degree in an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. • Certified Maintenance & Reliability Professional, preferred • Certified Reliability Engineer, preferred Experience: Experience working in a Union environment is preferred. Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma. Proficiency in Power BI is a plus Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in managing support of manufacturing and facilities equipment. Knowledge of SAP maintenance management systems. Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.
01/26/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews. Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment. Responsible for asset lifecycle management Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements Participate and provide support for audits. Lead, participate, and provide subject matter expertise in the design review and selection of new equipment. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements Participate in FAT, Commissioning of new and modified equipment Perform functional equivalency assessment of spare parts. In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment. Participate and provide support for audits. Develop business case for improvements requiring investments and participate in capital planning for assigned area. Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS) Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: • Bachelor's Degree in an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. • Certified Maintenance & Reliability Professional, preferred • Certified Reliability Engineer, preferred Experience: Experience working in a Union environment is preferred. Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma. Proficiency in Power BI is a plus Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in managing support of manufacturing and facilities equipment. Knowledge of SAP maintenance management systems. Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.
Summary: The Sr Manufacturing Process Mechanic role will routinely assist in performing sophisticated to critical processes according to Standard Operating Procedures in the Inspection and Packaging Operations Facility in Non Standard Shifts. Several positions available. Specific responsibilities include but are not limited to: Recognize and report malfunctions and make adjustments to equipment Responsible to increase equipment up time Understand how the equipment works and identify the causes of any abnormality. Help staff understand how the equipment can work at efficient condition Operate process automation and building monitoring systems. Assist in the evaluation and implementation of engineering improvements (like assist to optimize maintenance procedures, improve equipment reliability, changeover improvement, improve equipment utilization etc), policy changes, compliance, Improvements and optimization programs. Dispense raw materials and record transactions in appropriate system(s), preferred SAP May reconcile components and products, and calculate exposure to room temperature Act as a resource/trainer on manufacturing support tasks and/or in the use of all the equipment used in the area Act as Subject Matter Specialists (SMEs) for specific technical areas (e.g. equipment technical qualifications) May assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May perform revisions on routine SOPs Advance troubleshooting Initiate deviations records as appropriate. Perform basic, routine manufacturing process operations. Knowledge: Provides technical expertise, Facilitate Technical Information to staff on the line Applies specialized functional area skills and knowledge and underlying technical principles Integrates knowledge and experience as a skilled specialist May integrate knowledge of Amgen and business acuity to support the function Provides mentorship and technical advice to others Vision System Knowledge-Basic elements (how system work, inspection tool adjustment, etc) Problem Solving: Develops technical solutions to sophisticated problems which may impact multiple work areas or departments Applies creativity to solving technical problems Refers to established policies/precedents as needed Utilizes highly specialized tools for completing projects Work may require exercise of discretion and independent judgment to resolve problems Recommends and provide mentorship to resolve any equipment malfunction Recommends and assists in the implementation of changes to policies/ procedures as appropriate May develop new techniques and procedures leading to greater effectiveness and/or efficiency Autonomy: Receives general direction; work may be completed within established procedures Work guided by team requirements or department objectives as well as standard practices Establishes own priorities within general guidelines May act in a team lead capacity including delegating work to others May provide on-the-job training and technical mentorship to other team members Contribution: Provides customer service to internal and external clients Exchanges detailed technical information with customers to solve problems and/or provide ongoing support Contributes to department/unit through the quality and efficiency of work. May contribute to the department/unit by ensuring the accuracy of others' work and recommending quality guidelines Promote continuous improvements thinking Basic education and experience: Associate's degree & 4 years of maintenance experience in the Pharmaceutical, Medical Device and/or Biotech Manufacturing environment Or High School diploma and 6 years of maintenance experience in Pharmaceutical, Medical Device and/or Biotech Manufacturing environment Preferred qualifications: Educational background in Electronic Engineering Technology, Electric Technology, Mechanic Engineering Technology, Industrial Mechanics Available to work in Non Standard Shifts Previous experience as Mechanic Operator Knowledgeable of the following technical areas: Packaging or Process Equipment/System Maintenance Technician Negotiating skills Overall understanding of mechanical systems Capacity Planning/Inventory In depth understanding of Manufacturing/Pharma Business Organizational skills and an ability to perform assignments with a high degree of attention to detail Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment. Documentation skills. Written and oral communication skills. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
01/22/2021
Full time
Summary: The Sr Manufacturing Process Mechanic role will routinely assist in performing sophisticated to critical processes according to Standard Operating Procedures in the Inspection and Packaging Operations Facility in Non Standard Shifts. Several positions available. Specific responsibilities include but are not limited to: Recognize and report malfunctions and make adjustments to equipment Responsible to increase equipment up time Understand how the equipment works and identify the causes of any abnormality. Help staff understand how the equipment can work at efficient condition Operate process automation and building monitoring systems. Assist in the evaluation and implementation of engineering improvements (like assist to optimize maintenance procedures, improve equipment reliability, changeover improvement, improve equipment utilization etc), policy changes, compliance, Improvements and optimization programs. Dispense raw materials and record transactions in appropriate system(s), preferred SAP May reconcile components and products, and calculate exposure to room temperature Act as a resource/trainer on manufacturing support tasks and/or in the use of all the equipment used in the area Act as Subject Matter Specialists (SMEs) for specific technical areas (e.g. equipment technical qualifications) May assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records) May perform revisions on routine SOPs Advance troubleshooting Initiate deviations records as appropriate. Perform basic, routine manufacturing process operations. Knowledge: Provides technical expertise, Facilitate Technical Information to staff on the line Applies specialized functional area skills and knowledge and underlying technical principles Integrates knowledge and experience as a skilled specialist May integrate knowledge of Amgen and business acuity to support the function Provides mentorship and technical advice to others Vision System Knowledge-Basic elements (how system work, inspection tool adjustment, etc) Problem Solving: Develops technical solutions to sophisticated problems which may impact multiple work areas or departments Applies creativity to solving technical problems Refers to established policies/precedents as needed Utilizes highly specialized tools for completing projects Work may require exercise of discretion and independent judgment to resolve problems Recommends and provide mentorship to resolve any equipment malfunction Recommends and assists in the implementation of changes to policies/ procedures as appropriate May develop new techniques and procedures leading to greater effectiveness and/or efficiency Autonomy: Receives general direction; work may be completed within established procedures Work guided by team requirements or department objectives as well as standard practices Establishes own priorities within general guidelines May act in a team lead capacity including delegating work to others May provide on-the-job training and technical mentorship to other team members Contribution: Provides customer service to internal and external clients Exchanges detailed technical information with customers to solve problems and/or provide ongoing support Contributes to department/unit through the quality and efficiency of work. May contribute to the department/unit by ensuring the accuracy of others' work and recommending quality guidelines Promote continuous improvements thinking Basic education and experience: Associate's degree & 4 years of maintenance experience in the Pharmaceutical, Medical Device and/or Biotech Manufacturing environment Or High School diploma and 6 years of maintenance experience in Pharmaceutical, Medical Device and/or Biotech Manufacturing environment Preferred qualifications: Educational background in Electronic Engineering Technology, Electric Technology, Mechanic Engineering Technology, Industrial Mechanics Available to work in Non Standard Shifts Previous experience as Mechanic Operator Knowledgeable of the following technical areas: Packaging or Process Equipment/System Maintenance Technician Negotiating skills Overall understanding of mechanical systems Capacity Planning/Inventory In depth understanding of Manufacturing/Pharma Business Organizational skills and an ability to perform assignments with a high degree of attention to detail Capacity to follow written procedures, recognize and report malfunctions and make adjustments to equipment. Documentation skills. Written and oral communication skills. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description • Under general supervision supports utilities operations (plant and clean utility, ethanol, HVAC) • Ensures operations comply with cGMP and company standards for quality, health, safety and the environment • Investigates plant failures and operating incidents, determines cause and recommends and implements solutions • Analyzes maintenance history, waste and energy usage and process models and recommends improvement plans • Provides technical support, project briefs, system requirements and preliminary budgets for facility modifications, upgrades and capital projects • Maintains quality standards, risk assessments and CSL standard operating procedures (SOPs) Position Purpose: The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Position Qualifications and Experience Requirements: Education Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience Experience working in a Union environment is preferred but not required. Must have experience with leading mid-to-large capital projects for the pharmaceutical industry. Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Knowledge of CIP/SIP, clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Knowledge & experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Ability to write technical reports and to develop data gathering schedules. Ability to work on technical specifications and procurement details. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Knowledge of building management systems (Emerson, Rockwell) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
01/20/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description • Under general supervision supports utilities operations (plant and clean utility, ethanol, HVAC) • Ensures operations comply with cGMP and company standards for quality, health, safety and the environment • Investigates plant failures and operating incidents, determines cause and recommends and implements solutions • Analyzes maintenance history, waste and energy usage and process models and recommends improvement plans • Provides technical support, project briefs, system requirements and preliminary budgets for facility modifications, upgrades and capital projects • Maintains quality standards, risk assessments and CSL standard operating procedures (SOPs) Position Purpose: The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Position Qualifications and Experience Requirements: Education Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience Experience working in a Union environment is preferred but not required. Must have experience with leading mid-to-large capital projects for the pharmaceutical industry. Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Knowledge of CIP/SIP, clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Knowledge & experience in the design, implementation, operations and maintenance of clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Ability to write technical reports and to develop data gathering schedules. Ability to work on technical specifications and procurement details. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Knowledge of building management systems (Emerson, Rockwell) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the HVAC system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Responsible for cGMP facility design and improvement projects (Cleanrooms, Labs, ISO classes, HVAC, Refrigeration, Freezers, Environmental rooms, etc). Play an essential leadership role in the operation and troubleshooting of the utility systems. Serve as the subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Periodically review and assist with Building Air Balance Testing. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience:
01/20/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the HVAC system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Responsible for cGMP facility design and improvement projects (Cleanrooms, Labs, ISO classes, HVAC, Refrigeration, Freezers, Environmental rooms, etc). Play an essential leadership role in the operation and troubleshooting of the utility systems. Serve as the subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Periodically review and assist with Building Air Balance Testing. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience:
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews. Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment. Responsible for asset lifecycle management Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements Participate and provide support for audits. Lead, participate, and provide subject matter expertise in the design review and selection of new equipment. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements Participate in FAT, Commissioning of new and modified equipment Perform functional equivalency assessment of spare parts. In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment. Participate and provide support for audits. Develop business case for improvements requiring investments and participate in capital planning for assigned area. Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS) Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Certified Maintenance & Reliability Professional, preferred Certified Reliability Engineer, preferred Experience: Experience working in a Union environment is preferred. Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma. Proficiency in Power BI is a plus Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in managing support of manufacturing and facilities equipment. Knowledge of SAP maintenance management systems. Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.
01/20/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews. Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment. Responsible for asset lifecycle management Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements Participate and provide support for audits. Lead, participate, and provide subject matter expertise in the design review and selection of new equipment. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements Participate in FAT, Commissioning of new and modified equipment Perform functional equivalency assessment of spare parts. In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment. Participate and provide support for audits. Develop business case for improvements requiring investments and participate in capital planning for assigned area. Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS) Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Certified Maintenance & Reliability Professional, preferred Certified Reliability Engineer, preferred Experience: Experience working in a Union environment is preferred. Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma. Proficiency in Power BI is a plus Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in managing support of manufacturing and facilities equipment. Knowledge of SAP maintenance management systems. Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Position Purpose: The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the electrical system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will support operations, maintenance, manufacturing, automation, quality assurance, EHS, reliability engineering, project delivery and global engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the plant electrical systems. Assist with creating plans, perform equipment selection, load calculations and power system studies. Periodically review and update the Short Circuit Coordination Study. Responsible to support cGMP facility design and improvement projects. Play an essential leadership role in the operation and troubleshooting of the utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Perform regular field walk-through tours, inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Key member of the Energy and Sustainability initiatives. Drive development of the WAGES program. Collect, analyze and report data for use by the Utilities and Operations department. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and support development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the electrical system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating electrical drawings. Support small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Electrical Engineering with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience: Experience working in a Union environment is preferred but not required. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Must be able to read and interpret electrical and control drawings. Extensive knowledge of electrical design standards, IEEE, NFPA requirements and other codes related to design, safety and maintenance. Must have design and working experience with electrical power distribution at 115kV, 15kV and 480v. Must have Building design and commissioning experience. Must have design and working experience for the following types of equipment as a minimum: Generators, Switchgears, UPS, Inverters, Automatic Transfer Switches, Transformers, Harmonic Filters, Variable Frequency Drives, Motor Control Centers (MCC's), Motor Starters, Interior and Exterior Lighting and Power Management System. Experience performing Power Systems Studies using analysis software. (SKM Power Tools Preferred). Experience in electrical and instrumentation design in hazardous locations. Experience in electrical and instrumentation design in ISO clean room locations. Experience in security and access control systems. Experience in fire alarm and smoke control systems. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies: Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
01/15/2021
Full time
About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Position Purpose: The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the electrical system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will support operations, maintenance, manufacturing, automation, quality assurance, EHS, reliability engineering, project delivery and global engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Main Responsibilities and Accountabilities: Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the plant electrical systems. Assist with creating plans, perform equipment selection, load calculations and power system studies. Periodically review and update the Short Circuit Coordination Study. Responsible to support cGMP facility design and improvement projects. Play an essential leadership role in the operation and troubleshooting of the utility systems. Review and make recommendations to management for utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Perform regular field walk-through tours, inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Key member of the Energy and Sustainability initiatives. Drive development of the WAGES program. Collect, analyze and report data for use by the Utilities and Operations department. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and support development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the electrical system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating electrical drawings. Support small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Electrical Engineering with 5+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. Experience: Experience working in a Union environment is preferred but not required. Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Must be able to read and interpret electrical and control drawings. Extensive knowledge of electrical design standards, IEEE, NFPA requirements and other codes related to design, safety and maintenance. Must have design and working experience with electrical power distribution at 115kV, 15kV and 480v. Must have Building design and commissioning experience. Must have design and working experience for the following types of equipment as a minimum: Generators, Switchgears, UPS, Inverters, Automatic Transfer Switches, Transformers, Harmonic Filters, Variable Frequency Drives, Motor Control Centers (MCC's), Motor Starters, Interior and Exterior Lighting and Power Management System. Experience performing Power Systems Studies using analysis software. (SKM Power Tools Preferred). Experience in electrical and instrumentation design in hazardous locations. Experience in electrical and instrumentation design in ISO clean room locations. Experience in security and access control systems. Experience in fire alarm and smoke control systems. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP). Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures. Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP) Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Computer skills: MS Office Suite, MS Project, and AutoCAD. Competencies: Drives Results Business Insight Collaborates Situational Adaptability Communicates Effectively Customer Focus Organizational Savvy Plans and Aligns Resourcefulness
