Contamination Control Engineer - GMP

Job Title: Contamination Control Specialist

Location: Framingham, MA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• Leading as SME for specific subjects as part of the Contamination Control SOP
• Conducting risk assessments related to contamination control
• Overseeing sites activities and performance for contamination control systems in her/his scope of responsibilities
• Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
• Collaborating with cross‑functional teams to ensure product quality
• Ensuring presence on the shop floor to oversee practices, identify gaps vs SOP for contamination control
• Reviewing data from contamination control monitoring to propose improvements as necessary (from monitoring and trends)
• Participating in audits and regulatory inspections and audits, providing expertise on contamination control
• Supporting the preparation of validation protocol and supporting projects related to her/his area of expertise
• Contributing as an SME to specific CoE/CoP with Global functions; implementing on site the best practices shared

• Advise on contamination control protocols and procedures (A)
• Propose corrective and preventive actions to improve contamination controls (D)
• Advise cross‑functional teams on best practices or expected improvements in her/his area of expertise (A)
• Presence on the shopfloor with formal traceability of the observations. Inform management and feedback operators (A)
• Contribute to quality documentation SOP and validation protocol

• Bachelor's degree in Science or Engineering and a minimum of 6 years’ experience working in a regulated, cGXP environment or Master's degree and a minimum of 3 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.
• Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment

• Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with Sanofi GOP / Quality standards
• In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
• Communication skills to communicate with a large number of functions (from shopfloor to management) and to present complex subjects
• Ability to organize and lead routine investigations with a multi-disciplinary team

• Ability to gown and gain entry to controlled, classified areas

• Bring the miracles of science to life alongside a supportive, future‑focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave.

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; affectionate 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.

#GD-SG
#LI-GZ

#LI-Onsite
#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.