Job Summary Responsibilities include coordination of order flow from delivery creation in SAP to distribution of pick tickets to Warehouse Supervisors. This process includes, but is not limited to, transfer order printing, sorting, stamping, and routing. This position will monitor workflow, understanding the established priorities regarding both the warehouse operation and customer, utilizing SAP to select orders for processing to meet those needs. Responsibilities also include the investigation of complaints and deviations as assigned. Assist with the implementation of corrective and preventative actions from investigations, as well as internal/regulatory/customer audits for the Marketing Unit Distribution Center. This position reports directly to the Manager, Warehouse Operations or designated Supervisor. Responsibilities Monitors and manages the Delivery Due List in SAP, generating deliveries to the warehouse Order Fulfillment Team Monitors the workflow to keep current and consistent with the order volume issued Monitors activities of the Distribution Center in various stages: Receiving, Putaway, Replenishment, Picking, Packing, and Shipping to assist with deployment of workload Prioritizes order processing based on customer urgency, set order turnover deadlines/goals, and available staff/time Ensures shipments are properly posted and goods issued in SAP for prompt invoicing Creates and maintains reports concerning delivery volumes, productivity, and compliance Communicates and partners with internal business groups (Customer Operations, Quality Assurance, Compliance Units, Marketing, etc.) to manage the customer orders and material flow through the facility Assist in the performance of investigations regarding customer complaints and other deviations as directed Revise and create procedures within Documentum as needed and for the implementation of corrective/preventative actions from investigations and internal/regulatory/customer audits Initiate Change Controls for required GMP critical systems Performs all other tasks as directed Requirements A minimum of a 2-year college degree or equivalent experience and five years of experience in similar environment are required Must possess proficient math skills, excellent communication skills including facilitation abilities, writing skills, and effective problem-solving skills Excellent organizational skills with a high level of attention to detail Ability to work independently, as well as part of a team. Excellent working knowledge of SAP and data query Exhibit a strong knowledge of Microsoft Office Suite - Word, Excel, and PowerPoint Skills Computer literate to quickly learn Fresenius Kabi compliance systems (Documentum; TrackWise) and processes The ability to learn Fresenius Kabi practices and procedures as related to the operations within assigned Marketing Unit Distribution Center Strong analytical skills and an understanding of internal controls A strong sense of urgency and work ethic cGMP knowledge Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
11/10/2021
Full time
Job Summary Responsibilities include coordination of order flow from delivery creation in SAP to distribution of pick tickets to Warehouse Supervisors. This process includes, but is not limited to, transfer order printing, sorting, stamping, and routing. This position will monitor workflow, understanding the established priorities regarding both the warehouse operation and customer, utilizing SAP to select orders for processing to meet those needs. Responsibilities also include the investigation of complaints and deviations as assigned. Assist with the implementation of corrective and preventative actions from investigations, as well as internal/regulatory/customer audits for the Marketing Unit Distribution Center. This position reports directly to the Manager, Warehouse Operations or designated Supervisor. Responsibilities Monitors and manages the Delivery Due List in SAP, generating deliveries to the warehouse Order Fulfillment Team Monitors the workflow to keep current and consistent with the order volume issued Monitors activities of the Distribution Center in various stages: Receiving, Putaway, Replenishment, Picking, Packing, and Shipping to assist with deployment of workload Prioritizes order processing based on customer urgency, set order turnover deadlines/goals, and available staff/time Ensures shipments are properly posted and goods issued in SAP for prompt invoicing Creates and maintains reports concerning delivery volumes, productivity, and compliance Communicates and partners with internal business groups (Customer Operations, Quality Assurance, Compliance Units, Marketing, etc.) to manage the customer orders and material flow through the facility Assist in the performance of investigations regarding customer complaints and other deviations as directed Revise and create procedures within Documentum as needed and for the implementation of corrective/preventative actions from investigations and internal/regulatory/customer audits Initiate Change Controls for required GMP critical systems Performs all other tasks as directed Requirements A minimum of a 2-year college degree or equivalent experience and five years of experience in similar environment are required Must possess proficient math skills, excellent communication skills including facilitation abilities, writing skills, and effective problem-solving skills Excellent organizational skills with a high level of attention to detail Ability to work independently, as well as part of a team. Excellent working knowledge of SAP and data query Exhibit a strong knowledge of Microsoft Office Suite - Word, Excel, and PowerPoint Skills Computer literate to quickly learn Fresenius Kabi compliance systems (Documentum; TrackWise) and processes The ability to learn Fresenius Kabi practices and procedures as related to the operations within assigned Marketing Unit Distribution Center Strong analytical skills and an understanding of internal controls A strong sense of urgency and work ethic cGMP knowledge Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary This position reports to the Warehouse Supervisor. The Material Control Handler is responsible for performing duties associated with the preparation and delivery/staging of all components and raw materials used in production, as well as processing of returns from production. Responsible for preparation and shipment of all outgoing shipments to Company Distribution Centers, Company Manufacturing Plants, outside vendors, and other destinations within the U.S. and internationally as needed. Responsible for maintaining accurate inventories by performing cycle counting in support of continuous inventory cycle count program. Responsible for utilizing SAP operating system to perform all necessary transactions in support of production and Warehouse Management operations. Works across all functional areas within the plant. Works as part of the warehouse team. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT · Participates in continuous inventory cycle count program to ensure that requirements are met by performing cycle counting of inventories for components and raw materials used in manufacturing · Utilizes the SAP operating system to ensure that only approved material is used to supply materials to production to the appropriate staging area on time, accurately and according to the requirements of the Transfer Order · Responsible for the accurate preparation of all packaging requests and the staging of all WIP to the proper staging bay as required by the packaging schedule · Ensures the highest degree of safety when using any power equipment in the warehouse/facility, forklifts, aerial, lifts, power walkers, pallet jacks and remains qualified · Wears and uses appropriate safety equipment. · Maintains the highest level of cleanliness by following the applicable standard operating procedures and following established cGMP's and keeps all material off the floors and in the racks in assigned positions. · Participates in all company training and consistently completes all training requirements by use of the company's computer based training program · Responsible for picking and delivering all sample requests, component requests for testing, sampling and validation functions · Prepares all necessary SAP paperwork for Finished Goods shipment to the Distribution Center, and loads tractor trailers according to weight, number of pallets and DOT restrictions. Confirms all paperwork only after the truck is sealed and all paperwork has been signed by transporting driver. · Responsible for the safe storage of WIP, proprietary products, Validation, Clinical and Research lots according to designated storage location until needed. Applies proper identifying information to the pallets and secures pallets by netting and stretch wrapping. · Responsible for the processing of returns from the production areas after the completion of all production runs. · Removes all excess waste materials from the warehouse and transports to the designated disposal locations. · Complies with all Standard Operating Procedures, cGMP's, and company policies · Ability to work as part of a team, both internally within the department and externally with other departments and work independently with minimal supervision · Performs other duties as assigned REQUIREMENTS · Experience working with DEA and controlled substances is desired · Experience using SAP desired, other computers skills helpful · Must be able to lift 40 lbs, sort and lift components 6 - 8 hours a day. · Must be able to prioritize work loads to maintain production demands in a timely manner. · Must be able to operate powered equipment - forklifts, power walkers, man-lifts · Must be able to operate Material Handling equipment at heights of 35 - 40 feet. · Teamwork and cooperation skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
11/09/2021
Full time
Job Summary This position reports to the Warehouse Supervisor. The Material Control Handler is responsible for performing duties associated with the preparation and delivery/staging of all components and raw materials used in production, as well as processing of returns from production. Responsible for preparation and shipment of all outgoing shipments to Company Distribution Centers, Company Manufacturing Plants, outside vendors, and other destinations within the U.S. and internationally as needed. Responsible for maintaining accurate inventories by performing cycle counting in support of continuous inventory cycle count program. Responsible for utilizing SAP operating system to perform all necessary transactions in support of production and Warehouse Management operations. Works across all functional areas within the plant. Works as part of the warehouse team. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT · Participates in continuous inventory cycle count program to ensure that requirements are met by performing cycle counting of inventories for components and raw materials used in manufacturing · Utilizes the SAP operating system to ensure that only approved material is used to supply materials to production to the appropriate staging area on time, accurately and according to the requirements of the Transfer Order · Responsible for the accurate preparation of all packaging requests and the staging of all WIP to the proper staging bay as required by the packaging schedule · Ensures the highest degree of safety when using any power equipment in the warehouse/facility, forklifts, aerial, lifts, power walkers, pallet jacks and remains qualified · Wears and uses appropriate safety equipment. · Maintains the highest level of cleanliness by following the applicable standard operating procedures and following established cGMP's and keeps all material off the floors and in the racks in assigned positions. · Participates in all company training and consistently completes all training requirements by use of the company's computer based training program · Responsible for picking and delivering all sample requests, component requests for testing, sampling and validation functions · Prepares all necessary SAP paperwork for Finished Goods shipment to the Distribution Center, and loads tractor trailers according to weight, number of pallets and DOT restrictions. Confirms all paperwork only after the truck is sealed and all paperwork has been signed by transporting driver. · Responsible for the safe storage of WIP, proprietary products, Validation, Clinical and Research lots according to designated storage location until needed. Applies proper identifying information to the pallets and secures pallets by netting and stretch wrapping. · Responsible for the processing of returns from the production areas after the completion of all production runs. · Removes all excess waste materials from the warehouse and transports to the designated disposal locations. · Complies with all Standard Operating Procedures, cGMP's, and company policies · Ability to work as part of a team, both internally within the department and externally with other departments and work independently with minimal supervision · Performs other duties as assigned REQUIREMENTS · Experience working with DEA and controlled substances is desired · Experience using SAP desired, other computers skills helpful · Must be able to lift 40 lbs, sort and lift components 6 - 8 hours a day. · Must be able to prioritize work loads to maintain production demands in a timely manner. · Must be able to operate powered equipment - forklifts, power walkers, man-lifts · Must be able to operate Material Handling equipment at heights of 35 - 40 feet. · Teamwork and cooperation skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Manage and provide strategic direction / leadership for Customer and Technical Service Operations in the US, including Customer Service, Technical Service Back Office, Clinical Hotline, Product Complaints & Support, Demand Planning/Forecasting, Operational Training, Project Management and Analytics. Oversee the management of the day-to-day operations of Customer and Technical Service Support teams, including system order transaction and equipment master data integrity. Accountable for the strategic plan for the department, as well as leadership and team development. Manage, coach and develop employees and managers. Coordinate with field operations to ensure regional/global consistencies in process, data, and company objectives. Responsibilities Develop Customer and Technical Operation's financial budget - approx. $3.5M, strategic plan, and performance objectives. Direct responsibility for Customer and Technical Service operations as it relates to operational objectives / goals / results - consistency of process. Overall responsibility for > 30 corporate and field-based personnel. Ensure measurement and management of the Customer and Technical Operations day-to-day responsibilities, including order entry, product allocation, service call creation and closure, clinical/operational support, dispute management, quality support, training, project management, demand planning and analytics. Identify, develop, and implement departmental process improvement opportunities to enhance service to customers and aid the operation in achieving the vision and goals. Accountable for providing training and communication to staff and implementing initiatives to drive standardization and increased efficiency. Accountable for tracking and communicating department metrics and key performance indicators, as well as monitoring projects with team and liaison functions. Lead and participate in cross functional projects that result in operational improvements and cost savings. Accountable for employee compliance with established internal policies and practices. Accountable for ensuring that functional talent management objectives are met. Manage, establish and analyze plans to meet staffing and resource requirements. Ensure all talent management objectives are met through development planning and setting individual and group performance objectives. Overall responsibility for equipment master data - to include hardware installation / hardware tracking / configuration tracking. Overall responsibility for the management of hardware entitlements, PM planning, instrument warranty coverage, service billing invoices, and coordination with Sales Ops for applicable service contract proposals / renewals. Provide service logistic and operational support for new product launches, upgrades, FCAs across the marketing region. Responsible for periodic departmental operational audits and supporting quality related audits. Actively participate with and provide strategic perspective to the TCT leadership team. Lead the TCT Customer Experience program. Job Requirements Previous experience in leading multiple teams across various areas of responsibility with >20 FTEs. Demonstrate excellent leadership, customer service and communication skills. Ability to analyze and interpret data for effective growth strategies and problem solving. Excellent problem solving, interpersonal and decision-making skills. Ability to motivate, develop, train and promote a strong teamwork environment. Able to manage multiple priorities simultaneously. Strong ability to think innovatively and strategically. Must be results driven, detailed oriented and have strong project management skills. SAP knowledge a plus. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
11/02/2021
Full time
Job Summary Manage and provide strategic direction / leadership for Customer and Technical Service Operations in the US, including Customer Service, Technical Service Back Office, Clinical Hotline, Product Complaints & Support, Demand Planning/Forecasting, Operational Training, Project Management and Analytics. Oversee the management of the day-to-day operations of Customer and Technical Service Support teams, including system order transaction and equipment master data integrity. Accountable for the strategic plan for the department, as well as leadership and team development. Manage, coach and develop employees and managers. Coordinate with field operations to ensure regional/global consistencies in process, data, and company objectives. Responsibilities Develop Customer and Technical Operation's financial budget - approx. $3.5M, strategic plan, and performance objectives. Direct responsibility for Customer and Technical Service operations as it relates to operational objectives / goals / results - consistency of process. Overall responsibility for > 30 corporate and field-based personnel. Ensure measurement and management of the Customer and Technical Operations day-to-day responsibilities, including order entry, product allocation, service call creation and closure, clinical/operational support, dispute management, quality support, training, project management, demand planning and analytics. Identify, develop, and implement departmental process improvement opportunities to enhance service to customers and aid the operation in achieving the vision and goals. Accountable for providing training and communication to staff and implementing initiatives to drive standardization and increased efficiency. Accountable for tracking and communicating department metrics and key performance indicators, as well as monitoring projects with team and liaison functions. Lead and participate in cross functional projects that result in operational improvements and cost savings. Accountable for employee compliance with established internal policies and practices. Accountable for ensuring that functional talent management objectives are met. Manage, establish and analyze plans to meet staffing and resource requirements. Ensure all talent management objectives are met through development planning and setting individual and group performance objectives. Overall responsibility for equipment master data - to include hardware installation / hardware tracking / configuration tracking. Overall responsibility for the management of hardware entitlements, PM planning, instrument warranty coverage, service billing invoices, and coordination with Sales Ops for applicable service contract proposals / renewals. Provide service logistic and operational support for new product launches, upgrades, FCAs across the marketing region. Responsible for periodic departmental operational audits and supporting quality related audits. Actively participate with and provide strategic perspective to the TCT leadership team. Lead the TCT Customer Experience program. Job Requirements Previous experience in leading multiple teams across various areas of responsibility with >20 FTEs. Demonstrate excellent leadership, customer service and communication skills. Ability to analyze and interpret data for effective growth strategies and problem solving. Excellent problem solving, interpersonal and decision-making skills. Ability to motivate, develop, train and promote a strong teamwork environment. Able to manage multiple priorities simultaneously. Strong ability to think innovatively and strategically. Must be results driven, detailed oriented and have strong project management skills. SAP knowledge a plus. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Coordinates operational aspect of a packaging line including changeovers, quality issues, documentation, and distribution of resources. Consults with supervisor as necessary. Projects team work and positive energy to the assigned crew. Responsibilities Directs line personnel in processing of product (operational and procedural issues) Interacts with Quality Control, Maintenance, management, and peers in a professional manner. Verifies that all products and components are acceptable to be run through packaging operation. Sets-up and monitors equipment as necessary. Consults with Supervisor on line schedule, priorities, and short-term goals. Insures all procedures are properly followed when processing batches and that all required documentation is complete and accurate. Trains line personnel in set-up and use of equipment as necessary. Follows instructions as given by Shift Leader or Supervisor. REQUIREMENTS High School graduate or GED Three (3) years of pharmaceutical experience preferred Excellent technical skills. Must demonstrate proficiency in setting-up, operating, and changing over most packaging equipment including the following: labeler, SYStech vision system, Domino printer, LabelAire labeler, Shanklin/Texwrap shrink wrappers, vial loaders and all sensors. Must be eligible to work in the USA Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/25/2021
Full time
Job Summary Coordinates operational aspect of a packaging line including changeovers, quality issues, documentation, and distribution of resources. Consults with supervisor as necessary. Projects team work and positive energy to the assigned crew. Responsibilities Directs line personnel in processing of product (operational and procedural issues) Interacts with Quality Control, Maintenance, management, and peers in a professional manner. Verifies that all products and components are acceptable to be run through packaging operation. Sets-up and monitors equipment as necessary. Consults with Supervisor on line schedule, priorities, and short-term goals. Insures all procedures are properly followed when processing batches and that all required documentation is complete and accurate. Trains line personnel in set-up and use of equipment as necessary. Follows instructions as given by Shift Leader or Supervisor. REQUIREMENTS High School graduate or GED Three (3) years of pharmaceutical experience preferred Excellent technical skills. Must demonstrate proficiency in setting-up, operating, and changing over most packaging equipment including the following: labeler, SYStech vision system, Domino printer, LabelAire labeler, Shanklin/Texwrap shrink wrappers, vial loaders and all sensors. Must be eligible to work in the USA Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary POSITION SUMMARY The Director, BioSimilars Lab is responsible for the operation, leadership, and direction of Lab Operations dedicated to biosimilars development. The incumbent will build and lead a dynamic team of experienced scientists, providing expertise and leadership in all associated aspects of characterization technologies used in support of the development, heightened characterization and commercial manufacturing of recombinant proteins. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Create lab unit dedicated to biosimilars development, including hiring, equipment purchases, installation and qualification Develop platform to perform routine techniques such as: Size Exclusion, Bioassay, Reverse Phase, Ion Exchange, Hydrophilic Glycan Chromatography, (imaged) capillary electrophoresis and PAGE, Differential Scanning Calorimetry, Spectrophotometry. Manage and build a growing group of scientists dedicated to biosimilars, and oversee work performed Propose and implement analytical outsourcing strategy, balancing opportunities and risks. Oversee work done in collaboration with CROs in the areas above and on methods such as: 2D/3D structure, excipient testing, compendial testing. Keep abreast of technical development to maintain a state-of-the-art technology platform Review, edit, and approve internal reports supporting regulatory submissions Can act as team member in Development teams Manage performance and development of personnel to ensure achievement of organizational and department goals as well as motivation for high productivity Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget Develop analytical control strategy and support regulatory filings. Partner with the stakeholders and SMEs to align on priorities, resources, support and expertise as required Actively maintain knowledge of industry best practices related to bio-, binding and immunoassays and relevant technology Enable effective utilization of resources by ensuring robust employee development and performance management practices in area of responsibility Additionally: Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards. Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards. Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards. Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001. REQUIREMENTS PhD in Biochemistry, Analytical Chemistry, Cell Biology or related field with 10+ years relevant industry experience; MS with 15+ years of industry experience in Pharma/Diagnostic industry required 7+ years' experience with bioassays and immunoassays 5+Years' experience in managing direct reports Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable Demonstrated ability to lead programs and/or projects, ability to influence and must have strong communication skills. Recognized Thought leader and strongly networked in the field of bioassays, binding and immunoassays. Familiarity with microbiological safety and viral clearance aspects of bio-manufacturing and control and testing strategy Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders. Demonstrated and significant experience with bioanalytical methods, such ELISA, cell-based reporter assays, antibody effector function assays and viral assays. Excellent verbal and written communication skills required Ability to understand and interpret federal regulations and company operating procedures Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/25/2021
Full time
Job Summary POSITION SUMMARY The Director, BioSimilars Lab is responsible for the operation, leadership, and direction of Lab Operations dedicated to biosimilars development. The incumbent will build and lead a dynamic team of experienced scientists, providing expertise and leadership in all associated aspects of characterization technologies used in support of the development, heightened characterization and commercial manufacturing of recombinant proteins. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Create lab unit dedicated to biosimilars development, including hiring, equipment purchases, installation and qualification Develop platform to perform routine techniques such as: Size Exclusion, Bioassay, Reverse Phase, Ion Exchange, Hydrophilic Glycan Chromatography, (imaged) capillary electrophoresis and PAGE, Differential Scanning Calorimetry, Spectrophotometry. Manage and build a growing group of scientists dedicated to biosimilars, and oversee work performed Propose and implement analytical outsourcing strategy, balancing opportunities and risks. Oversee work done in collaboration with CROs in the areas above and on methods such as: 2D/3D structure, excipient testing, compendial testing. Keep abreast of technical development to maintain a state-of-the-art technology platform Review, edit, and approve internal reports supporting regulatory submissions Can act as team member in Development teams Manage performance and development of personnel to ensure achievement of organizational and department goals as well as motivation for high productivity Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget Develop analytical control strategy and support regulatory filings. Partner with the stakeholders and SMEs to align on priorities, resources, support and expertise as required Actively maintain knowledge of industry best practices related to bio-, binding and immunoassays and relevant technology Enable effective utilization of resources by ensuring robust employee development and performance management practices in area of responsibility Additionally: Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards. Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards. Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards. Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001. REQUIREMENTS PhD in Biochemistry, Analytical Chemistry, Cell Biology or related field with 10+ years relevant industry experience; MS with 15+ years of industry experience in Pharma/Diagnostic industry required 7+ years' experience with bioassays and immunoassays 5+Years' experience in managing direct reports Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable Demonstrated ability to lead programs and/or projects, ability to influence and must have strong communication skills. Recognized Thought leader and strongly networked in the field of bioassays, binding and immunoassays. Familiarity with microbiological safety and viral clearance aspects of bio-manufacturing and control and testing strategy Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders. Demonstrated and significant experience with bioanalytical methods, such ELISA, cell-based reporter assays, antibody effector function assays and viral assays. Excellent verbal and written communication skills required Ability to understand and interpret federal regulations and company operating procedures Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Coordinates operational aspect of a packaging line including changeovers, quality issues, documentation, and distribution of resources. Consults with supervisor as necessary. Projects team work and positive energy to the assigned crew. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Directs line personnel in processing of product (operational and procedural issues) Interacts with Quality Control, Maintenance, management, and peers in a professional manner. Verifies that all products and components are acceptable to be run through packaging operation. Sets-up and monitors equipment as necessary. Consults with Supervisor on line schedule, priorities, and short-term goals. Insures all procedures are properly followed when processing batches and that all required documentation is complete and accurate. Trains line personnel in set-up and use of equipment as necessary. Follows instructions as given by Shift Leader or Supervisor. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/25/2021
Full time
Job Summary Coordinates operational aspect of a packaging line including changeovers, quality issues, documentation, and distribution of resources. Consults with supervisor as necessary. Projects team work and positive energy to the assigned crew. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Directs line personnel in processing of product (operational and procedural issues) Interacts with Quality Control, Maintenance, management, and peers in a professional manner. Verifies that all products and components are acceptable to be run through packaging operation. Sets-up and monitors equipment as necessary. Consults with Supervisor on line schedule, priorities, and short-term goals. Insures all procedures are properly followed when processing batches and that all required documentation is complete and accurate. Trains line personnel in set-up and use of equipment as necessary. Follows instructions as given by Shift Leader or Supervisor. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Responsible for the day-to-day supervision of 30 - 50 employees on the Inspection and Packaging lines. Provides oversight to ensure a safe, effective and efficient process for inspection and packaging a quality product. Ensures department meets all quality standards by following all applicable SOP's and cGMP's. Has a thorough understanding of all batch record pages and reviews all documentation during production and reconciliation to prevent errors. Accuracy and attention to detail is a critical aspect of this position. Must relate professionally with support groups and all levels within the organization. Responsibilities 1. Day to day supervision of 30 - 50 employees across multiple Inspection / Packaging lines. 2. Coordinates the execution of production schedules based upon customer demand. 3. Interacts with departmental supervisors and support groups on maintaining compliance with methods, standards, policies and cGMP's. 4. Completes all batch related documentation according to site release standards. 5. Assumes responsibility of their assigned department during course of shift. 6. Write Investigation reports as they pertain to Inspection / Packaging errors. 7. Defines, recommends and performs corrective and preventative actions. 8. Writes Mitigation plans as needed. 9. Update and enhance departmental SOP's. 10. Contributes to development of annual departmental operating budget. 11. Regularly evaluates performance of Inspection / Packaging personnel. 12. Coordinates application of operators in assigned areas of responsibility. 13. Develop, execute and track training and follow-up programs to ensure adequate staff development. 14. Establishes effective communication methods to provide continuity of information across all shifts. 15. Provides a daily update on performance. 16. Assume other duties and responsibilities as assigned. 17. Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System. 18. Responsible for ensuring Health, Safety and Environmental requirements are adhered to REQUIREMENTS Bachelor's degree and/or related equivalent experience. 3 - 5 years in an FDA regulated industry. Good oral and written communication skills. Working knowledge of SOP's and cGMP's.. Accuracy and attention to detail. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/24/2021
Full time
Job Summary Responsible for the day-to-day supervision of 30 - 50 employees on the Inspection and Packaging lines. Provides oversight to ensure a safe, effective and efficient process for inspection and packaging a quality product. Ensures department meets all quality standards by following all applicable SOP's and cGMP's. Has a thorough understanding of all batch record pages and reviews all documentation during production and reconciliation to prevent errors. Accuracy and attention to detail is a critical aspect of this position. Must relate professionally with support groups and all levels within the organization. Responsibilities 1. Day to day supervision of 30 - 50 employees across multiple Inspection / Packaging lines. 2. Coordinates the execution of production schedules based upon customer demand. 3. Interacts with departmental supervisors and support groups on maintaining compliance with methods, standards, policies and cGMP's. 4. Completes all batch related documentation according to site release standards. 5. Assumes responsibility of their assigned department during course of shift. 6. Write Investigation reports as they pertain to Inspection / Packaging errors. 7. Defines, recommends and performs corrective and preventative actions. 8. Writes Mitigation plans as needed. 9. Update and enhance departmental SOP's. 10. Contributes to development of annual departmental operating budget. 11. Regularly evaluates performance of Inspection / Packaging personnel. 12. Coordinates application of operators in assigned areas of responsibility. 13. Develop, execute and track training and follow-up programs to ensure adequate staff development. 14. Establishes effective communication methods to provide continuity of information across all shifts. 15. Provides a daily update on performance. 16. Assume other duties and responsibilities as assigned. 17. Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System. 18. Responsible for ensuring Health, Safety and Environmental requirements are adhered to REQUIREMENTS Bachelor's degree and/or related equivalent experience. 3 - 5 years in an FDA regulated industry. Good oral and written communication skills. Working knowledge of SOP's and cGMP's.. Accuracy and attention to detail. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary The Sr. Manager, Sales Operations for our Biosimilars Portfolio Launch will be responsible for all sales operational activities, including forecasting, build and implement sales reports and analytics, build incentive compensation programs, sales force structuring, sizing, targeting and deployment, business systems and data management. Prepares and summarizes sales analysis to identify key trends and identify opportunities to maximize sales force effectiveness. Maintains sales analytics and customer relationship management (CRM) tools for the sales team and management. Supports regional business directors and key account managers and collaborates with internal stakeholders. Responsibilities Assists in the planning, direction and development of an integrated processes. Proactive leader who manages workload and deadline requirements; prioritizes and allocates resources. Builds and provides geographical sales analysis, including: trend analysis, strategic planning, regional data, product rankings, market segmentation, call analysis and other miscellaneous sales reports. Applies strategic and competitive market intelligence within department analytics and collaborates with Marketing, Marketing Analytics, Medical Affairs and Market Access to align forecast with sales targets. Provide strategic and visionary recommendations; review the analysis and business drivers based on competitive trends and contract award drivers. Builds and analyzes focused programs for the sales team, including special recognition programs. Build field incentive compensation program and monitor and track field force impact on IC and adherence to call plan through updated reporting. Develops analytical tools for the sales team, and responsible for upkeep of sales reports. Analyzes territory trends such as customer type, customer calls, GPO contracts, and sales results in order to maximize sales force effectiveness. Assist in training new field-based employees on applicable sales reporting tools and territory management practices. Communicates findings, trend analyses and recommendations verbally and in writing to management and other stakeholders. Develops and manages reporting templates and dashboards used to analyze and interpret sales data. Ensure data quality of all outgoing reports and analyses. Identify process improvement opportunities and develop or enhance tools to assist in the work deliverables. Evaluate financial results of relevant business areas in Sales and Marketing. Identify and analyze appropriate market/product trends and provide summary reports of monthly KPI's to sales leadership. Requirements Bachelor's degree required, MBA or equivalent experience preferred. Must be analytical, collaborative, have excellent organization skills, with the ability to prioritize projects. Minimum of 7 years of pharmaceutical/biotech experience, including 3 years of demonstrated success/leadership in pharmaceutical/biotech sales operations and sales analytic experience with supporting a field sales organization. Minimum of 2 years oncology and biosimilar experience preferred. Demonstrated success in implementation and or management of CRM platforms, developing and managing incentive compensation programs, sales reports & analytics and business systems. Strong verbal and written communication skills required. Experience in building and leading a sales operation/analytics team when applicable. Ability to work independently. Must have advanced skills in Microsoft Excel with proficiency in Word and PowerPoint; Access and Qlik Sense data visualization software experience preferred. Excellent team player with strong interpersonal skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/24/2021
Full time
Job Summary The Sr. Manager, Sales Operations for our Biosimilars Portfolio Launch will be responsible for all sales operational activities, including forecasting, build and implement sales reports and analytics, build incentive compensation programs, sales force structuring, sizing, targeting and deployment, business systems and data management. Prepares and summarizes sales analysis to identify key trends and identify opportunities to maximize sales force effectiveness. Maintains sales analytics and customer relationship management (CRM) tools for the sales team and management. Supports regional business directors and key account managers and collaborates with internal stakeholders. Responsibilities Assists in the planning, direction and development of an integrated processes. Proactive leader who manages workload and deadline requirements; prioritizes and allocates resources. Builds and provides geographical sales analysis, including: trend analysis, strategic planning, regional data, product rankings, market segmentation, call analysis and other miscellaneous sales reports. Applies strategic and competitive market intelligence within department analytics and collaborates with Marketing, Marketing Analytics, Medical Affairs and Market Access to align forecast with sales targets. Provide strategic and visionary recommendations; review the analysis and business drivers based on competitive trends and contract award drivers. Builds and analyzes focused programs for the sales team, including special recognition programs. Build field incentive compensation program and monitor and track field force impact on IC and adherence to call plan through updated reporting. Develops analytical tools for the sales team, and responsible for upkeep of sales reports. Analyzes territory trends such as customer type, customer calls, GPO contracts, and sales results in order to maximize sales force effectiveness. Assist in training new field-based employees on applicable sales reporting tools and territory management practices. Communicates findings, trend analyses and recommendations verbally and in writing to management and other stakeholders. Develops and manages reporting templates and dashboards used to analyze and interpret sales data. Ensure data quality of all outgoing reports and analyses. Identify process improvement opportunities and develop or enhance tools to assist in the work deliverables. Evaluate financial results of relevant business areas in Sales and Marketing. Identify and analyze appropriate market/product trends and provide summary reports of monthly KPI's to sales leadership. Requirements Bachelor's degree required, MBA or equivalent experience preferred. Must be analytical, collaborative, have excellent organization skills, with the ability to prioritize projects. Minimum of 7 years of pharmaceutical/biotech experience, including 3 years of demonstrated success/leadership in pharmaceutical/biotech sales operations and sales analytic experience with supporting a field sales organization. Minimum of 2 years oncology and biosimilar experience preferred. Demonstrated success in implementation and or management of CRM platforms, developing and managing incentive compensation programs, sales reports & analytics and business systems. Strong verbal and written communication skills required. Experience in building and leading a sales operation/analytics team when applicable. Ability to work independently. Must have advanced skills in Microsoft Excel with proficiency in Word and PowerPoint; Access and Qlik Sense data visualization software experience preferred. Excellent team player with strong interpersonal skills. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Responsibilities include coordination of order flow from delivery creation in SAP to distribution of pick tickets to Warehouse Supervisors. This process includes, but is not limited to, transfer order printing, sorting, stamping, and routing. This position will monitor workflow, understanding the established priorities regarding both the warehouse operation and customer, utilizing SAP to select orders for processing to meet those needs. Responsibilities also include the investigation of complaints and deviations as assigned. Assist with the implementation of corrective and preventative actions from investigations, as well as internal/regulatory/customer audits for the Marketing Unit Distribution Center. This position reports directly to the Manager, Warehouse Operations or designated Supervisor. Responsibilities Monitors and manages the Delivery Due List in SAP, generating deliveries to the warehouse Order Fulfillment Team Monitors the workflow to keep current and consistent with the order volume issued Monitors activities of the Distribution Center in various stages: Receiving, Putaway, Replenishment, Picking, Packing, and Shipping to assist with deployment of workload Prioritizes order processing based on customer urgency, set order turnover deadlines/goals, and available staff/time Ensures shipments are properly posted and goods issued in SAP for prompt invoicing Creates and maintains reports concerning delivery volumes, productivity, and compliance Communicates and partners with internal business groups (Customer Operations, Quality Assurance, Compliance Units, Marketing, etc.) to manage the customer orders and material flow through the facility Assist in the performance of investigations regarding customer complaints and other deviations as directed Revise and create procedures within Documentum as needed and for the implementation of corrective/preventative actions from investigations and internal/regulatory/customer audits Initiate Change Controls for required GMP critical systems Performs all other tasks as directed Requirements A minimum of a 2-year college degree or equivalent experience and five years of experience in similar environment are required Must possess proficient math skills, excellent communication skills including facilitation abilities, writing skills, and effective problem-solving skills Excellent organizational skills with a high level of attention to detail Ability to work independently, as well as part of a team. Excellent working knowledge of SAP and data query Exhibit a strong knowledge of Microsoft Office Suite - Word, Excel, and PowerPoint Skills Computer literate to quickly learn Fresenius Kabi compliance systems (Documentum; TrackWise) and processes The ability to learn Fresenius Kabi practices and procedures as related to the operations within assigned Marketing Unit Distribution Center Strong analytical skills and an understanding of internal controls A strong sense of urgency and work ethic cGMP knowledge Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/24/2021
Full time
Job Summary Responsibilities include coordination of order flow from delivery creation in SAP to distribution of pick tickets to Warehouse Supervisors. This process includes, but is not limited to, transfer order printing, sorting, stamping, and routing. This position will monitor workflow, understanding the established priorities regarding both the warehouse operation and customer, utilizing SAP to select orders for processing to meet those needs. Responsibilities also include the investigation of complaints and deviations as assigned. Assist with the implementation of corrective and preventative actions from investigations, as well as internal/regulatory/customer audits for the Marketing Unit Distribution Center. This position reports directly to the Manager, Warehouse Operations or designated Supervisor. Responsibilities Monitors and manages the Delivery Due List in SAP, generating deliveries to the warehouse Order Fulfillment Team Monitors the workflow to keep current and consistent with the order volume issued Monitors activities of the Distribution Center in various stages: Receiving, Putaway, Replenishment, Picking, Packing, and Shipping to assist with deployment of workload Prioritizes order processing based on customer urgency, set order turnover deadlines/goals, and available staff/time Ensures shipments are properly posted and goods issued in SAP for prompt invoicing Creates and maintains reports concerning delivery volumes, productivity, and compliance Communicates and partners with internal business groups (Customer Operations, Quality Assurance, Compliance Units, Marketing, etc.) to manage the customer orders and material flow through the facility Assist in the performance of investigations regarding customer complaints and other deviations as directed Revise and create procedures within Documentum as needed and for the implementation of corrective/preventative actions from investigations and internal/regulatory/customer audits Initiate Change Controls for required GMP critical systems Performs all other tasks as directed Requirements A minimum of a 2-year college degree or equivalent experience and five years of experience in similar environment are required Must possess proficient math skills, excellent communication skills including facilitation abilities, writing skills, and effective problem-solving skills Excellent organizational skills with a high level of attention to detail Ability to work independently, as well as part of a team. Excellent working knowledge of SAP and data query Exhibit a strong knowledge of Microsoft Office Suite - Word, Excel, and PowerPoint Skills Computer literate to quickly learn Fresenius Kabi compliance systems (Documentum; TrackWise) and processes The ability to learn Fresenius Kabi practices and procedures as related to the operations within assigned Marketing Unit Distribution Center Strong analytical skills and an understanding of internal controls A strong sense of urgency and work ethic cGMP knowledge Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Responsible for assembling, operating and monitoring a state of the art, aseptic filling machine in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination as well as understand advanced computerized systems through HMI. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Ability to operate advanced HMI applications. Set-up, fine-tune, operate, and troubleshoot state of the art filling machine with Isolator to meet process parameters. Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level; anticipating needed equipment, parts, and supplies. Comply with current SOP's and GMPs. Maintains and understands aseptic manufacturing principles related to isolator technology. Documents work accurately and timely. Technical comprehension of mechanical functions and controls for filling equipment and isolator. Works in a time efficient manner while maintaining adherence to all applicable SOP's . Adept at problem solving. Specifically to identifying problem, developing solution, and execution of remedy and elevate to management if necessary. Concise communication with co-workers and managers to promote teamwork atmosphere. The ability to multi-task. Understand the process flow and step by step requirements for manufacturing. Reconciles components and product. Perform other duties as directed. REQUIREMENTS Associate Degree plus 3-5 years of pharmaceutical experience required or BS degree in Engineering or Sciences or 7+ years of pharmaceutical Filling/Isolator experience Advanced HMI aptitude Experience in reading CAD mechanical and electrical drawings preferred Experience in FDA regulated work environment Can lift up to 30lbs Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/24/2021
Full time
Job Summary Responsible for assembling, operating and monitoring a state of the art, aseptic filling machine in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination as well as understand advanced computerized systems through HMI. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Ability to operate advanced HMI applications. Set-up, fine-tune, operate, and troubleshoot state of the art filling machine with Isolator to meet process parameters. Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level; anticipating needed equipment, parts, and supplies. Comply with current SOP's and GMPs. Maintains and understands aseptic manufacturing principles related to isolator technology. Documents work accurately and timely. Technical comprehension of mechanical functions and controls for filling equipment and isolator. Works in a time efficient manner while maintaining adherence to all applicable SOP's . Adept at problem solving. Specifically to identifying problem, developing solution, and execution of remedy and elevate to management if necessary. Concise communication with co-workers and managers to promote teamwork atmosphere. The ability to multi-task. Understand the process flow and step by step requirements for manufacturing. Reconciles components and product. Perform other duties as directed. REQUIREMENTS Associate Degree plus 3-5 years of pharmaceutical experience required or BS degree in Engineering or Sciences or 7+ years of pharmaceutical Filling/Isolator experience Advanced HMI aptitude Experience in reading CAD mechanical and electrical drawings preferred Experience in FDA regulated work environment Can lift up to 30lbs Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Job Summary Technician will be responsible for assembling, operating and monitoring a state of the art equipment in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of, and practice good aseptic technique to minimize potential for product contamination. Must also have some mechanical knowledge (hands-on troubleshooting and adjusting equipment) as well as understand navigation of advanced computerized systems via HMI. Responsibilities Documentation/Process Comply with current SOP's and GMP's. Document work accurately and timely. Reconcile components and product. Understand the process flow and step by step requirements for manufacturing. Work in a time efficient manner while maintaining adherence to all applicable SOP's. Technical Control equipment through advanced HMI applications. Understand and follow aseptic practices. Operate sterilization and parts washing equipment. Operate vial washing and depyrogenation equipment. Multi-task and learn multiple manufacturing areas. Mechanical Set-up, fine-tune, and troubleshoot vial washer and depyrogenation tunnel. Load component sterilizer and parts washer. Others Concise communication with co-workers and managers to promote teamwork atmosphere. Clean and sanitize equipment and production rooms. Perform other duties as assigned. Transfer materials from debox and preparation areas to manufacturing areas. Follow safety requirements and promote a safe work environment. REQUIREMENTS High School Diploma or equivalent and a minimum of 1 year of manufacturing experience. Experience in the pharmaceutical or food industries a plus. Aseptic experience strongly preferred. Must be able to understand, speak, and write English in order to comply with necessary SOP's, SPEC's, Job-specific training materials, GMP's, and other manuals. Basic and/or advanced math skills. Basic mechanical aptitude Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
09/23/2021
Full time
Job Summary Technician will be responsible for assembling, operating and monitoring a state of the art equipment in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of, and practice good aseptic technique to minimize potential for product contamination. Must also have some mechanical knowledge (hands-on troubleshooting and adjusting equipment) as well as understand navigation of advanced computerized systems via HMI. Responsibilities Documentation/Process Comply with current SOP's and GMP's. Document work accurately and timely. Reconcile components and product. Understand the process flow and step by step requirements for manufacturing. Work in a time efficient manner while maintaining adherence to all applicable SOP's. Technical Control equipment through advanced HMI applications. Understand and follow aseptic practices. Operate sterilization and parts washing equipment. Operate vial washing and depyrogenation equipment. Multi-task and learn multiple manufacturing areas. Mechanical Set-up, fine-tune, and troubleshoot vial washer and depyrogenation tunnel. Load component sterilizer and parts washer. Others Concise communication with co-workers and managers to promote teamwork atmosphere. Clean and sanitize equipment and production rooms. Perform other duties as assigned. Transfer materials from debox and preparation areas to manufacturing areas. Follow safety requirements and promote a safe work environment. REQUIREMENTS High School Diploma or equivalent and a minimum of 1 year of manufacturing experience. Experience in the pharmaceutical or food industries a plus. Aseptic experience strongly preferred. Must be able to understand, speak, and write English in order to comply with necessary SOP's, SPEC's, Job-specific training materials, GMP's, and other manuals. Basic and/or advanced math skills. Basic mechanical aptitude Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.