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Job Information

Sanofi Group Principal Quality Engineer in Framingham, Massachusetts

Position Title

Senior/Principal Quality Engineer – QA Operations

Location

Framingham, Massachusetts

Who We Are

The Quality Assurance (QA) department is responsible for quality oversight of operations

at Sanofi Framingham Biologics facilities. QA main responsibility is to ensure adherence to

CGMPs during manufacturing operations through partnership with the site and direct

engagement with daily operations activities. QA is responsible for providing support and

guidance to the Sanofi Operations function in order to protect the safety, quality and

efficacy of Sanofi’s products, thereby ensuring the availability of compliant and safe

products for our patients and assuring the security of the company’s business and global

markets.

Where We Are

Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service.

Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations. Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.

Job Highlights

  • Provide input and support of CAPA and Deviation Quality System improvement initiatives.

  • Perform the Quality Assurance review and approval of complex change controls, deviations, Environmental Monitoring/Critical Utility investigations, laboratory investigations, and CAPAs to ensure that they meet the requirements of Sanofi standards and procedures, and are clearly and appropriately justified.

  • Perform product complaint investigations.

  • Generate and present assigned metrics at the required frequency which drive accountability and delivery of targets.

  • Participate in and/or lead formal risk assessments.

  • Work with project teams to determine the change control approach for complex projects.

  • Ensure that changes affecting more than one site are evaluated and approved through the multi-site change control process. Perform quality SME assessments.

  • Work closely with the Operational Excellence to support continuous improvement of quality and manufacturing systems using SMS tools and implementation of actions arising from Lean and other continuous improvement events.

  • Perform the review and approval of technical documents and determine interrelated impacts to process and systems. Ensure completeness and correctness of items such as engineering studies, Validation protocols, Technical Reports, Engineering drawings and MBRs/SOPs.

Basic Qualifications

  • Bachelor's degree in Science or Engineering and a minimum of 6-9 years’ experience working in a regulated, cGXP environment or Master's degree and a minimum of 3-6 years’ experience working in a regulated, cGXP environment.

  • Operations experience in one or more of the following areas: Quality Assurance, Quality

  • Control, Manufacturing Technical Support, Facilities Engineering, or Automation.

  • Demonstrated knowledge of cGXP regulations and guidance. Demonstrated experience

  • with change control, CAPA and deviation quality systems.

  • Demonstrated experience with project management.

  • Demonstrated proficiency in critical thinking and technical writing.

Preferred Qualifications

  • Experience with SMS, LEAN (problem solving/use of Lean tools) or comparable continuous improvement systems.

  • Experience with root cause analysis tools and gap identification.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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