Contamination Control Engineer - GMP

Job Title: Contamination Control Specialist

Location: Framingham, MA

About the Job

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

About Sanofi:
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.

Main Responsibilities:

• 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

Key Involvement in Decision Making Process (D=Decision, A=Advisor, I=Informed)

•  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

About You

Expected Experience

• 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

Expected Technical Skills

• 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

Special Working Conditions

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

Why Choose Us

• 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; 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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