Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action. What You Will Achieve Working with Pfizer's dynamic engineering team, the Training and Compliance Coordinator is primarily responsible for ensuring training and compliance within the Engineering Maintenance and Utilities group, including reviewing, evaluating, and working with the team to resolve potential compliance issues within the organization's manufacturing facilities. The individual in this role will ensure that employees are adequately trained and systems are compliant with the rules and regulations of Pfizer as well as industry regulatory agencies. The Training and Compliance Coordinator will be responsible for monitoring, reporting, and aiding in remediating any compliance issues as well as tracking completion of compliance related commitments and manufacturing investigation reports. The Training and Compliance Coordinator will also be responsible for coordinating with Subject Matter Experts (SME's) and other departments during site audits. The Training and Compliance Coordinator will also be responsible for reviewing current group training curricula's, develop role specific modules to minimize unnecessary trainings and conducting training as needed. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Develop and conduct compliance reviews, assessments, analyses, and other business engagement activities within established frameworks to identify, track, and report on the remediation of compliance gaps Create, maintain, and monitor compliance systems to ensure effectiveness in all manufacturing areas Develop and prepare meaningful reporting and tracking of compliance activities to enable effective communication to senior management and all facilities Assist in the ongoing development and enhancement of the compliance program Keep current on emerging compliance issues and trends Assist with and oversee compliance training needs in all departments and areas in Engineering. Supervise the submission of responses to regulatory agencies Develop and maintain relationships with quality organizations. Create, maintain, improve, and track the Company's standard operating procedures and policies in collaboration with Engineering Lead investigation and resolution into compliance concerns Create and manage effective action plans in response to audit discoveries and compliance violations. Assess company operations to determine compliance risk. Ensure all employees are educated on the latest regulations and processes Qualifications Must-Have Bachelor's Degree 5+ years of demonstrated experience in product development, manufacturing science and technology, within the pharmaceutical industry Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control The ideal candidate will be well organized, detailed oriented, and have strong problem-solving skills work comfortably under pressure, and deliver on tight deadlines. The Training and Compliance Coordinator should be confident, professional, and self-motivated with a keen interest in the ethical, legal, and regulatory requirements of a business. Top candidates will have outstanding presentation and report writing skills, with the ability to work on their own initiative and as part of a team. Ability to follow written procedures and monitor others for adherence to written procedures. Ability to create or update written procedures with site operations personnel Team player with strong interpersonal skills. Open-minded self-starter with the ability to adapt and problem solve, as well manage multiple tasks concurrently. Nice-to-Have Master's degree Relevant pharmaceutical experience Demonstrated ability to train and coach others Experience with Six Sigma or other operational excellence programs In-depth knowledge of drug substance/drug substance intermediate manufacturing technology PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits, and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions. As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate can remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation. Role is primarily office-sitting, standing, walking, and bending. This is inclusive of leading/participating in Webex. Perform complex data analysis for process analysis, troubleshooting or process improvement. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Standard M-F on-site work week, days. No travel required. Other Job Details: Last Date to Apply for Job: 9/24/21 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Engineering #LI-PFE
09/10/2021
Full time
Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action. What You Will Achieve Working with Pfizer's dynamic engineering team, the Training and Compliance Coordinator is primarily responsible for ensuring training and compliance within the Engineering Maintenance and Utilities group, including reviewing, evaluating, and working with the team to resolve potential compliance issues within the organization's manufacturing facilities. The individual in this role will ensure that employees are adequately trained and systems are compliant with the rules and regulations of Pfizer as well as industry regulatory agencies. The Training and Compliance Coordinator will be responsible for monitoring, reporting, and aiding in remediating any compliance issues as well as tracking completion of compliance related commitments and manufacturing investigation reports. The Training and Compliance Coordinator will also be responsible for coordinating with Subject Matter Experts (SME's) and other departments during site audits. The Training and Compliance Coordinator will also be responsible for reviewing current group training curricula's, develop role specific modules to minimize unnecessary trainings and conducting training as needed. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Develop and conduct compliance reviews, assessments, analyses, and other business engagement activities within established frameworks to identify, track, and report on the remediation of compliance gaps Create, maintain, and monitor compliance systems to ensure effectiveness in all manufacturing areas Develop and prepare meaningful reporting and tracking of compliance activities to enable effective communication to senior management and all facilities Assist in the ongoing development and enhancement of the compliance program Keep current on emerging compliance issues and trends Assist with and oversee compliance training needs in all departments and areas in Engineering. Supervise the submission of responses to regulatory agencies Develop and maintain relationships with quality organizations. Create, maintain, improve, and track the Company's standard operating procedures and policies in collaboration with Engineering Lead investigation and resolution into compliance concerns Create and manage effective action plans in response to audit discoveries and compliance violations. Assess company operations to determine compliance risk. Ensure all employees are educated on the latest regulations and processes Qualifications Must-Have Bachelor's Degree 5+ years of demonstrated experience in product development, manufacturing science and technology, within the pharmaceutical industry Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control The ideal candidate will be well organized, detailed oriented, and have strong problem-solving skills work comfortably under pressure, and deliver on tight deadlines. The Training and Compliance Coordinator should be confident, professional, and self-motivated with a keen interest in the ethical, legal, and regulatory requirements of a business. Top candidates will have outstanding presentation and report writing skills, with the ability to work on their own initiative and as part of a team. Ability to follow written procedures and monitor others for adherence to written procedures. Ability to create or update written procedures with site operations personnel Team player with strong interpersonal skills. Open-minded self-starter with the ability to adapt and problem solve, as well manage multiple tasks concurrently. Nice-to-Have Master's degree Relevant pharmaceutical experience Demonstrated ability to train and coach others Experience with Six Sigma or other operational excellence programs In-depth knowledge of drug substance/drug substance intermediate manufacturing technology PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits, and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions. As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate can remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation. Role is primarily office-sitting, standing, walking, and bending. This is inclusive of leading/participating in Webex. Perform complex data analysis for process analysis, troubleshooting or process improvement. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Standard M-F on-site work week, days. No travel required. Other Job Details: Last Date to Apply for Job: 9/24/21 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Engineering #LI-PFE
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
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The Specialist I, QA is responsible for assisting and supporting, Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This entry-level position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, supply chain management, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Support/execute QA on the Floor program • Support/execute Raw Material release • Support/execute Batch Record review of executed/Master Batch Records • Support/execute revision and creation of Standard Operating Procedures in document management system • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA • Support QA oversite for incoming commercial and clinical projects • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues. • Support the generation of QA operations metrics • Approve Quality Notifications (Deviations, CAPA's and Change Controls) • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues • Receive assignments in the form of objectives to help achieve department goals • Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality) • Participate in company sponsored training • Support regulatory and client audits • Provide Quality input/support to investigations, CAPA's and changes • Support site inspection readiness strategy and activities • Support internal audits per audit schedule The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BS degree or equivalent years of experience in the field. • Minimum 8 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records • Preferred experience in biologic drug substance manufacture • Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry. • Strong computer skills with the Microsoft Office product line. • Moderate understanding of regulations governing document control and records management. • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations. • Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards • Strong communication skills: oral/written and listening • Ability to work individually and in a team environment • Ability to work under pressure and analyze processes within scheduled timeframes • Strong presentation skills, including written and verbal communication skills • Experience in SAP and Technical Writing IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
01/28/2021
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The Specialist I, QA is responsible for assisting and supporting, Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This entry-level position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, supply chain management, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Support/execute QA on the Floor program • Support/execute Raw Material release • Support/execute Batch Record review of executed/Master Batch Records • Support/execute revision and creation of Standard Operating Procedures in document management system • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA • Support QA oversite for incoming commercial and clinical projects • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues. • Support the generation of QA operations metrics • Approve Quality Notifications (Deviations, CAPA's and Change Controls) • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues • Receive assignments in the form of objectives to help achieve department goals • Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality) • Participate in company sponsored training • Support regulatory and client audits • Provide Quality input/support to investigations, CAPA's and changes • Support site inspection readiness strategy and activities • Support internal audits per audit schedule The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BS degree or equivalent years of experience in the field. • Minimum 8 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records • Preferred experience in biologic drug substance manufacture • Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry. • Strong computer skills with the Microsoft Office product line. • Moderate understanding of regulations governing document control and records management. • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations. • Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards • Strong communication skills: oral/written and listening • Ability to work individually and in a team environment • Ability to work under pressure and analyze processes within scheduled timeframes • Strong presentation skills, including written and verbal communication skills • Experience in SAP and Technical Writing IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The QA Specialist II professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Rockville Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation. • Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data • Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.) • Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges • SOP generation, review and/or approval • Own quality records (Deviation/CAPA/Change Control). • Manage and support the Complaint program • APR generation and approval • Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals • Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions. • Lead and support additional work as required. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • Bachelor's Degree in Scientific or related fields • A minimum of seven (7) years of cGMP Quality experience • Product and Raw material disposition is a must • Well versed in SAP is a must • Batch Record review is a must • Strong Commercial manufacturing experience (Large Molecules) required • Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must • Experienced with US, EU pharmaceutical regulations, and ISO standards • Expert Knowledge and application of GMP principles • Excellent communication skills: oral, written and listening • Ability to influence without authority across cross-functional organization IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
01/24/2021
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The QA Specialist II professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Rockville Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation. • Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data • Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.) • Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges • SOP generation, review and/or approval • Own quality records (Deviation/CAPA/Change Control). • Manage and support the Complaint program • APR generation and approval • Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals • Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions. • Lead and support additional work as required. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • Bachelor's Degree in Scientific or related fields • A minimum of seven (7) years of cGMP Quality experience • Product and Raw material disposition is a must • Well versed in SAP is a must • Batch Record review is a must • Strong Commercial manufacturing experience (Large Molecules) required • Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must • Experienced with US, EU pharmaceutical regulations, and ISO standards • Expert Knowledge and application of GMP principles • Excellent communication skills: oral, written and listening • Ability to influence without authority across cross-functional organization IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The Specialist I, QA is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. The employee will have a potential for growth and development in all areas of quality support such as supporting internal/external inspections, validation protocol and report approval, document control, supply chain management, as well as supporting change control, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Technical and quality review of validation protocols and reports. • Support/execute QA on the Floor program. • Support/execute Raw Material release. • Support/execute Batch Record review of executed/Master Batch Records. • Support/execute revision and creation of Standard Operating Procedures in document management system. • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA. • Support QA oversite for incoming commercial and clinical projects. • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues. • Support the generation of QA operations metrics. • Approve Quality Notifications (Deviations, CAPA's and Change Controls). • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues. • Receive assignments in the form of objectives to help achieve department goals. • Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality). • Participate in company sponsored training. • Support regulatory and client audits as well as internal audits per audit schedule. • Provide Quality input/support to investigations, CAPA's and changes. • Support site inspection readiness strategy and activities. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BS degree and 8+ years of experience in GMP testing or manufacturing. • Ideal candidate will have previous roles that leverages technical expertise in supporting validation, manufacturing or analytical laboratory testing. • Minimum of 5 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records. • Preferred experience in biologic drug substance manufacture. • Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry. • Strong computer skills with the Microsoft Office product line. • Moderate understanding of regulations governing document control and records management. • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations. • Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards. • Strong communication skills: oral/written and listening. • Ability to work individually and in a team environment. • Ability to work under pressure and analyze processes within scheduled timeframes. • Strong presentation skills, including written and verbal communication skills. • Experience in SAP and Technical Writing. IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
01/23/2021
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The Specialist I, QA is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. The employee will have a potential for growth and development in all areas of quality support such as supporting internal/external inspections, validation protocol and report approval, document control, supply chain management, as well as supporting change control, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Technical and quality review of validation protocols and reports. • Support/execute QA on the Floor program. • Support/execute Raw Material release. • Support/execute Batch Record review of executed/Master Batch Records. • Support/execute revision and creation of Standard Operating Procedures in document management system. • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA. • Support QA oversite for incoming commercial and clinical projects. • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues. • Support the generation of QA operations metrics. • Approve Quality Notifications (Deviations, CAPA's and Change Controls). • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues. • Receive assignments in the form of objectives to help achieve department goals. • Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality). • Participate in company sponsored training. • Support regulatory and client audits as well as internal audits per audit schedule. • Provide Quality input/support to investigations, CAPA's and changes. • Support site inspection readiness strategy and activities. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BS degree and 8+ years of experience in GMP testing or manufacturing. • Ideal candidate will have previous roles that leverages technical expertise in supporting validation, manufacturing or analytical laboratory testing. • Minimum of 5 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records. • Preferred experience in biologic drug substance manufacture. • Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry. • Strong computer skills with the Microsoft Office product line. • Moderate understanding of regulations governing document control and records management. • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations. • Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards. • Strong communication skills: oral/written and listening. • Ability to work individually and in a team environment. • Ability to work under pressure and analyze processes within scheduled timeframes. • Strong presentation skills, including written and verbal communication skills. • Experience in SAP and Technical Writing. IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
Title: Senior Validation Specialist Location: Warren, NJ Start date: ASAP Responsibilities: The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls. Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures. Schedules and performs periodic review of validated computer systems Conducts investigations into qualification failures, develops and implements remediation plans Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques. Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity. Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates. Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to the company standards. Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests. Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment. Promotes and maintains compliance with corporate, safety and regulatory policies. Maintains all required Corporate, Facilities and EHS training as required Champions adherence to and improvement of all safety procedures and hazard communication Requirements: BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent 7 years of combined experience in FDA-regulated GMP lab environment Must have experience validating and using common lab equipment and stand-alone computerized lab systems Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas. Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems Strong experience writing and executing system validation & equipment qualification documents Ability to interact effectively with laboratory personnel, QA, and Facilities groups Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation Innate ability to learn new software as required for equipment qualification and system validations. Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
01/21/2021
Full time
Title: Senior Validation Specialist Location: Warren, NJ Start date: ASAP Responsibilities: The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls. Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures. Schedules and performs periodic review of validated computer systems Conducts investigations into qualification failures, develops and implements remediation plans Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques. Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity. Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates. Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to the company standards. Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests. Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment. Promotes and maintains compliance with corporate, safety and regulatory policies. Maintains all required Corporate, Facilities and EHS training as required Champions adherence to and improvement of all safety procedures and hazard communication Requirements: BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent 7 years of combined experience in FDA-regulated GMP lab environment Must have experience validating and using common lab equipment and stand-alone computerized lab systems Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas. Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems Strong experience writing and executing system validation & equipment qualification documents Ability to interact effectively with laboratory personnel, QA, and Facilities groups Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation Innate ability to learn new software as required for equipment qualification and system validations. Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatu2019s why weu2019re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Weu2019re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our location in Alameda, CA currently has an opportunity for a Senior Regulatory Affairs Specialist.u00A0 u00A0 This new Senior Regulatory Affairs Specialist position at ADC will focus on US regulatory submissions and change management for our next generation sensing products. Prior FDA submission experience or a background in software products is preferred, as well as project management experience. This is an exciting opportunity to lead submissions for new products in evolving regulatory areas such as the digital space. u00A0 u00A0 u00A0 As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.u00A0 The individual may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.u00A0 The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for FDA submission.u00A0 The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development. u00A0 WHAT YOUu2019LL DO Assist in SOP development and review Provide regulatory input to product lifecycle planning Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions Assist in the development of regional regulatory strategy Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval Determine trade issues to anticipate regulatory obstacle Determine and communicate submission and approval requirements Participate in risk benefit analysis for regulatory compliance Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts Assist with label development and review for compliance before release Submit and review change controls to determine the level of change and consequent submission requirements Provide regulatory input for product recalls and recall communications. u00A0 EDUCATION AND EXPERIENCE YOUu2019LL BRING u00A0 At least three (3) years of regulatory affairs experience within medical devices (preferred) or pharma, ideally with class III PMA products. FDA/EU or international regulatory experience is required. Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.u00A0 Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: A fast-paced work environment where your contribution is essential to success Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:u00A0 u00A0 Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. u00A0 Connect with us at , on Facebook at and on
01/15/2021
Full time
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatu2019s why weu2019re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Weu2019re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our location in Alameda, CA currently has an opportunity for a Senior Regulatory Affairs Specialist.u00A0 u00A0 This new Senior Regulatory Affairs Specialist position at ADC will focus on US regulatory submissions and change management for our next generation sensing products. Prior FDA submission experience or a background in software products is preferred, as well as project management experience. This is an exciting opportunity to lead submissions for new products in evolving regulatory areas such as the digital space. u00A0 u00A0 u00A0 As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.u00A0 The individual may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.u00A0 The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for FDA submission.u00A0 The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development. u00A0 WHAT YOUu2019LL DO Assist in SOP development and review Provide regulatory input to product lifecycle planning Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions Assist in the development of regional regulatory strategy Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval Determine trade issues to anticipate regulatory obstacle Determine and communicate submission and approval requirements Participate in risk benefit analysis for regulatory compliance Assess the acceptability of quality, preclinical and clinical documentation for submission filing Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval Assist compliance with product post marketing approval requirements Review regulatory aspects of contracts Assist with label development and review for compliance before release Submit and review change controls to determine the level of change and consequent submission requirements Provide regulatory input for product recalls and recall communications. u00A0 EDUCATION AND EXPERIENCE YOUu2019LL BRING u00A0 At least three (3) years of regulatory affairs experience within medical devices (preferred) or pharma, ideally with class III PMA products. FDA/EU or international regulatory experience is required. Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.u00A0 Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: A fast-paced work environment where your contribution is essential to success Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:u00A0 u00A0 Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. u00A0 Connect with us at , on Facebook at and on
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Senior Specialist, Data Integrity Quality Operations responsibilities are to identify, analyze, and evaluate potential Data Integrity risks throughout the full data lifecycle in processes and systems across the organization. Responsibilities Performs Data Lifecycle Pathway Mappings to identify potential Data Integrity risks, and work with cross-functional stakeholders to define the corrective and preventative measures (CAPAs) and related mitigation of risks. Facilitates the identification of high vulnerable data processes and systems (via high-level assessments). Determines strategy and collaborates with team members and functional SME's to drive the execution of data mappings. Systematically describes the data in processes, systems, and equipment throughout the data lifecycle (creation, processing, review, reporting, retention, and destruction of data). Serves as the subject matter expert for performing data mappings. Identifies risks to data integrity associated with the business process flow and the data flow throughout the data lifecycle. Analyzes and performs a quantitate evaluation of the identified risks. Determines controls to mitigate, reduce, or eliminate data integrity risks, aligning with functional SME is to assign ownership of the identified actions. Ensures the completed data mapping report is archived. Develop and maintain a tool for sharing of completed data maps across the network. Shares lessons learnt / best practices identified / opportunities for alignment / productivity improvements to the relevant stakeholders. Identifies and maintains a network of functional Subject Matter Experts (SME) (e.g. QC, QA Ops and Compliance, Manufacturing, MS&T, Engineering, Regulatory, Clinical Operations, Global Patent Safety, Pharmacovigilance, Pre-clinical functions). Works closely with the Site Data Integrity Lead to execute the data mappings. Continuously improves data integrity knowledge base and understanding of functional SME's by highlighting how process improvements or systems upgrades / reconfiguration can strengthen the controls in place to ensure the integrity of data. Conducts data mapping methodology awareness sessions with functional SME's. Plans onsite or virtual meetings and workshops with the functional SME's. Coordinates with functional SME's to perform pre-work, including a review of process/procedures related to the process/system under evaluation and review of any DI related deviations and/or inspection findings for the system/process. Supports audits related to Data Integrity for both internal and external parties. Supports preparation for regulatory/health authority inspections and/or response development for DI related topics. Drives, monitors and assures delivery of the Data Mapping Execution Plan, and periodically report status/progress to site DI leads and/or site leadership, the organization DI Lead and/or the organization Quality Leadership Team and Novartis Group Quality. Promotes DI reporting aligned with Speak-Up office for DI relevant cases to assure they are managed appropriately across the interface between the Speak-Up office and Quality Investigation and corrective/preventative action processes. Escalates any critical gaps identified during data mapping. Evaluates if an existing data map may require update associated with changes to how data are recorded, processed, reviewed, reported, retained or destroyed. Leads and mentors assigned employees. Other Related duties as assigned. Qualifications B.S. degree in a scientific discipline. 7 years' experience supporting GxP activities. In-depth knowledge of FDA regulations and GMP systems in a highly regulated or pharmaceutical / biotech facility. Cross-functional experience in one or more of the following GxP regulated functions (e.g Quality Assurance or Quality Control, Clinical Operations, PV, Pre-Clinical Operations, Manufacturing / Engineering / Automation operations, Quality Management Departments or equivalent external consultant positions. Good knowledge of the application of ALCOA+ principles and 21CFR Part 11 requirements in paper, hybrid and electronic systems. Strong operational background preferred. Strong focus on details and data with significant experience in quality risk management principles. Experience with handling raw data during the different stages of the data lifecycle preferred. Direct industry Data Integrity related experience an advantage. Experience working with diverse stakeholders, with ability to drive and manage change. Experience with and understanding of data flows in electronic systems. Strong experience in supporting risk analysis, project management, communication and presentation skills. Ability to synthesize detailed information and provide clear communication and messaging across functions. 25% travel. Novartis Gene Therapies Compensation and Benefit Summary: The salary range for this role is from $94,000/year to $150,000/year. The base salary ultimately offered may vary based on the successful candidate's qualifications. The level of this role will also be determined based on the successful candidate's qualifications. Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-MG1
01/15/2021
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Senior Specialist, Data Integrity Quality Operations responsibilities are to identify, analyze, and evaluate potential Data Integrity risks throughout the full data lifecycle in processes and systems across the organization. Responsibilities Performs Data Lifecycle Pathway Mappings to identify potential Data Integrity risks, and work with cross-functional stakeholders to define the corrective and preventative measures (CAPAs) and related mitigation of risks. Facilitates the identification of high vulnerable data processes and systems (via high-level assessments). Determines strategy and collaborates with team members and functional SME's to drive the execution of data mappings. Systematically describes the data in processes, systems, and equipment throughout the data lifecycle (creation, processing, review, reporting, retention, and destruction of data). Serves as the subject matter expert for performing data mappings. Identifies risks to data integrity associated with the business process flow and the data flow throughout the data lifecycle. Analyzes and performs a quantitate evaluation of the identified risks. Determines controls to mitigate, reduce, or eliminate data integrity risks, aligning with functional SME is to assign ownership of the identified actions. Ensures the completed data mapping report is archived. Develop and maintain a tool for sharing of completed data maps across the network. Shares lessons learnt / best practices identified / opportunities for alignment / productivity improvements to the relevant stakeholders. Identifies and maintains a network of functional Subject Matter Experts (SME) (e.g. QC, QA Ops and Compliance, Manufacturing, MS&T, Engineering, Regulatory, Clinical Operations, Global Patent Safety, Pharmacovigilance, Pre-clinical functions). Works closely with the Site Data Integrity Lead to execute the data mappings. Continuously improves data integrity knowledge base and understanding of functional SME's by highlighting how process improvements or systems upgrades / reconfiguration can strengthen the controls in place to ensure the integrity of data. Conducts data mapping methodology awareness sessions with functional SME's. Plans onsite or virtual meetings and workshops with the functional SME's. Coordinates with functional SME's to perform pre-work, including a review of process/procedures related to the process/system under evaluation and review of any DI related deviations and/or inspection findings for the system/process. Supports audits related to Data Integrity for both internal and external parties. Supports preparation for regulatory/health authority inspections and/or response development for DI related topics. Drives, monitors and assures delivery of the Data Mapping Execution Plan, and periodically report status/progress to site DI leads and/or site leadership, the organization DI Lead and/or the organization Quality Leadership Team and Novartis Group Quality. Promotes DI reporting aligned with Speak-Up office for DI relevant cases to assure they are managed appropriately across the interface between the Speak-Up office and Quality Investigation and corrective/preventative action processes. Escalates any critical gaps identified during data mapping. Evaluates if an existing data map may require update associated with changes to how data are recorded, processed, reviewed, reported, retained or destroyed. Leads and mentors assigned employees. Other Related duties as assigned. Qualifications B.S. degree in a scientific discipline. 7 years' experience supporting GxP activities. In-depth knowledge of FDA regulations and GMP systems in a highly regulated or pharmaceutical / biotech facility. Cross-functional experience in one or more of the following GxP regulated functions (e.g Quality Assurance or Quality Control, Clinical Operations, PV, Pre-Clinical Operations, Manufacturing / Engineering / Automation operations, Quality Management Departments or equivalent external consultant positions. Good knowledge of the application of ALCOA+ principles and 21CFR Part 11 requirements in paper, hybrid and electronic systems. Strong operational background preferred. Strong focus on details and data with significant experience in quality risk management principles. Experience with handling raw data during the different stages of the data lifecycle preferred. Direct industry Data Integrity related experience an advantage. Experience working with diverse stakeholders, with ability to drive and manage change. Experience with and understanding of data flows in electronic systems. Strong experience in supporting risk analysis, project management, communication and presentation skills. Ability to synthesize detailed information and provide clear communication and messaging across functions. 25% travel. Novartis Gene Therapies Compensation and Benefit Summary: The salary range for this role is from $94,000/year to $150,000/year. The base salary ultimately offered may vary based on the successful candidate's qualifications. The level of this role will also be determined based on the successful candidate's qualifications. Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-MG1
Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron's sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines Supporting small manufacturing, engineering, and validation projects Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action Authoring or updating system specifications, user and functional requirements specifications, generating and executing vital Factory Acceptance Tests (FAT) and (Site Acceptance Testing) SAT protocols This job might be for you if you: Want to support our extraordinary team to produce the highest quality medicines for patients as efficiently as possible to change people's lives. Want to challenge the status-quo and champion an environment where continuous improvement is not just metrics - it's a mentality for everyone, every day, to do better. Enjoy project-oriented work with a career goal of becoming a domain specialist. Have a knack for compiling documentation and enjoy it! Don't get frustrated with a meticulous process of change control, investigations and corrective actions. To be considered for our Automation Engineer position, we prefer a BS in Engineering or a related field. We expect you to have least 2 years of experience in the design and maintenance of process control systems and/or data acquisition systems. Senior level Engineers should have at least 5 years of experience in this area. You should be able to demonstrate strong skills developing, troubleshooting and maintaining PLCs and HMI systems in a pharmaceutical / biopharmaceutical manufacturing facility. We may also consider applicants with at least 8 years of proven, relevant experience as Principal Automation Engineers. Level will be determined based on qualifications relevant to the role. We use Allen-Bradley and Siemens control system products and video graphic chart recorders; specific knowledge with these products is ideal. Our Automation Engineers are smart, flexible troubleshooters. We thrive in a culture of trust, teamwork, and transparency. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DR1
01/15/2021
Full time
Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron's sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures Using PLCs and HMIs to provide technical support and solutions to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines Supporting small manufacturing, engineering, and validation projects Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action Authoring or updating system specifications, user and functional requirements specifications, generating and executing vital Factory Acceptance Tests (FAT) and (Site Acceptance Testing) SAT protocols This job might be for you if you: Want to support our extraordinary team to produce the highest quality medicines for patients as efficiently as possible to change people's lives. Want to challenge the status-quo and champion an environment where continuous improvement is not just metrics - it's a mentality for everyone, every day, to do better. Enjoy project-oriented work with a career goal of becoming a domain specialist. Have a knack for compiling documentation and enjoy it! Don't get frustrated with a meticulous process of change control, investigations and corrective actions. To be considered for our Automation Engineer position, we prefer a BS in Engineering or a related field. We expect you to have least 2 years of experience in the design and maintenance of process control systems and/or data acquisition systems. Senior level Engineers should have at least 5 years of experience in this area. You should be able to demonstrate strong skills developing, troubleshooting and maintaining PLCs and HMI systems in a pharmaceutical / biopharmaceutical manufacturing facility. We may also consider applicants with at least 8 years of proven, relevant experience as Principal Automation Engineers. Level will be determined based on qualifications relevant to the role. We use Allen-Bradley and Siemens control system products and video graphic chart recorders; specific knowledge with these products is ideal. Our Automation Engineers are smart, flexible troubleshooters. We thrive in a culture of trust, teamwork, and transparency. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DR1
Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
The mission of our Drug Product Project Management team is to lead drug product lifecycle management by successfully leading projects that support tech transfer, novel technology, and process improvements. As a Project Specialist on this team, you will lead well defined Drug Product (DP) sub-projects to support the overall portfolios managed by the Drug Product Project Managers. Additionally, you may also support, plan and coordinate operational tasks under the guidance of a Project Manager. If you enjoy inspiring change on a variety of projects, this role could be for you. As a Project Specialist, a typical day might include the following: Functioning as a project lead on at least one well defined Drug Product sub-project. Maintaining and executing DP-PM project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools to facilitate planning and coordination of deliverables for each assigned DP Project. Utilizing basic project management techniques to develop and maintain planning tools (Spreadsheets, MS Project etc.) in support of projects in order to facilitate standardization and coordination across functional areas. Developing working relationships with department leaders, line managers and individuals within each functional group utilizing open communication skills. Implementing tools used by the DP Project team(s). you would be directly responsible for the maintenance and accuracy of planning files as well as project update reports for all assigned projects. Developing and maintaining the organizational structure of shared databases. Traveling up to 10%. This job might be for you if you: Are passionate about leading projects and prioritizing using strong organizational, communication and time management skills Have a knack for identifying and implementing solutions to improve information sharing processes. Enjoy reviewing documents and would be excited to participate in compiling information for regulatory filings. Are skilled at planning and tracking project activities. Enjoy facilitating meetings with internal and external partner teams (technical transfer, validation, new product launch, etc.). Have demonstrated strengths with strong interpersonal, cross-cultural, communication, and problem-solving skills. Exhibit a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment. Are adept at fostering a productive team environment to one common project objective. Take a proactive stance on resolution of project related issues with tact, diplomacy and composure. Exhibit confidence and a high emotional IQ. Are proficient in sophisticated techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. To be considered for the Senior Project Specialist-Drug Product position, you must have a BA/BS, preferably in a physical or biological science or engineering, and 5 years project management-related experience. We would also consider applicants with a Master's degree and 4+ years of equivalent experience or an Associate degree and equivalent experience. Applicants with a BA/BS and at least 2 years of relevant experience may be considered for a Project Specialist-Drug Product role. Experience in pharmaceutical or medical device industry in manufacturing, technical, or quality related roles is desirable. PMP certification or MBA is a plus. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DR1
01/15/2021
Full time
The mission of our Drug Product Project Management team is to lead drug product lifecycle management by successfully leading projects that support tech transfer, novel technology, and process improvements. As a Project Specialist on this team, you will lead well defined Drug Product (DP) sub-projects to support the overall portfolios managed by the Drug Product Project Managers. Additionally, you may also support, plan and coordinate operational tasks under the guidance of a Project Manager. If you enjoy inspiring change on a variety of projects, this role could be for you. As a Project Specialist, a typical day might include the following: Functioning as a project lead on at least one well defined Drug Product sub-project. Maintaining and executing DP-PM project plans, timelines, agendas, resourcing requirements, rolling summaries, base lining and other tools to facilitate planning and coordination of deliverables for each assigned DP Project. Utilizing basic project management techniques to develop and maintain planning tools (Spreadsheets, MS Project etc.) in support of projects in order to facilitate standardization and coordination across functional areas. Developing working relationships with department leaders, line managers and individuals within each functional group utilizing open communication skills. Implementing tools used by the DP Project team(s). you would be directly responsible for the maintenance and accuracy of planning files as well as project update reports for all assigned projects. Developing and maintaining the organizational structure of shared databases. Traveling up to 10%. This job might be for you if you: Are passionate about leading projects and prioritizing using strong organizational, communication and time management skills Have a knack for identifying and implementing solutions to improve information sharing processes. Enjoy reviewing documents and would be excited to participate in compiling information for regulatory filings. Are skilled at planning and tracking project activities. Enjoy facilitating meetings with internal and external partner teams (technical transfer, validation, new product launch, etc.). Have demonstrated strengths with strong interpersonal, cross-cultural, communication, and problem-solving skills. Exhibit a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment. Are adept at fostering a productive team environment to one common project objective. Take a proactive stance on resolution of project related issues with tact, diplomacy and composure. Exhibit confidence and a high emotional IQ. Are proficient in sophisticated techniques with relevant software: MS Project, Excel, PowerPoint, Word, etc. To be considered for the Senior Project Specialist-Drug Product position, you must have a BA/BS, preferably in a physical or biological science or engineering, and 5 years project management-related experience. We would also consider applicants with a Master's degree and 4+ years of equivalent experience or an Associate degree and equivalent experience. Applicants with a BA/BS and at least 2 years of relevant experience may be considered for a Project Specialist-Drug Product role. Experience in pharmaceutical or medical device industry in manufacturing, technical, or quality related roles is desirable. PMP certification or MBA is a plus. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DR1