Sanofi · 11 hours ago
Contamination Control Engineer - GMP
Framingham, MA
Full-time
Onsite
Mid, Senior Level
$74K/yr - $107K/yr
3+ years expSanofi is a global biopharma company committed to improving people's lives through innovative treatments. The Contamination Control Engineer will lead contamination control efforts, conduct risk assessments, and collaborate with cross-functional teams to ensure product quality in a regulated environment.
Health CareLife SciencePharmaceuticalTherapeutics
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
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
Qualification
Required
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (83)
2024 (69)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
MarketScreener
2025-12-31
2025-12-30
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