Sanofi Group Principal Quality Engineer in Framingham, Massachusetts
Senior Quality Engineer – Digital
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
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.
Support IT System Administration and user access for select systems.
Support digital auditing activities for identified systems to drive compliance.
Enable Digital solution implementation via project support and post-launch activities.
Participate in and/or lead formal risk assessments.
Perform the review and approval of technical documents and determine interrelated impacts to process and systems, such as engineering studies, Validation protocols, Technical Reports, Engineering drawings and MBRs/SOPs.
Perform the Quality Assurance review and approval of complex change controls, deviations/investigations and CAPAs to ensure that they meet the requirements of company standards and procedures and are clearly and appropriately justified.
Support Data Integrity of digital platforms to meet regulatory requirements
Experience administering ALCOA+ in support of both digital and paper processes, also known as hybrid processes.
Bachelor’s Degree in a scientific field (Biology, Information Technology, Engineering or equivalent.) and 6 years’ experience in a Quality and /or other cGMP related field or Master’s Degree in a scientific field and 4 years’ experience in a Quality and /or other cGMP related field.
Knowledge in external agency regulations (FDA, EMA, etc.)
Able to understand computer systems in a more technical way and translate this into everyday end user application.
Strong computer, verbal and written communication skills and proficient in Microsoft Office.
Experience in quality systems.
Ability to adapt to changing priorities and work in a cross-functional team.
Experience with SMS (problem solving/use of Lean tools) or comparable continuous improvement systems.
Experience with root cause analysis tools and gap identification.3+ years’ experience in a Quality Assurance role.
Experience in bio-pharmaceutical industry.
Capable of analyzing trends and metrics that lead to improvement.
Strong technical writing skills.
Effective time management, attention to detail, organizational skills, teamwork
Significant capability in problem solving methodology.
Experience training and developing employees.
Experience participating in external agency inspections.
Knowledge of regulatory enforcement trends
Ability to work independently.
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.
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.