Contamination Control Engineer - GMP

Sanofi • Framingham, MA

15d • $74,250 - $107,250 • Onsite

About The Position

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.

Requirements

• 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

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees