Contamination Control Specialist

Job Title: Contamination Control Specialist
Location: Framingham, MA

About The Job:

The Sterility Assurance and Microbiology (Contamination Control) Department supports quality and manufacturing activities at Sanofi Framingham Biologics Campus by identifying possible trends from microbial contaminants that may interfere with the quality of the product during different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the areas are operating in a state of environmental control.

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 specific subjects part of the Contamination Control SOP in her/his area of expertise
• 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 Roles

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

Additional Accountabilities

• 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

About You:

Basic Qualifications

• Bachelor's degree in Life Sciences, Sciences, Engineering or other related fields with 8+ years experience working in a regulated, cGXP environment OR
• Master's degree in Life Sciences, Sciences, Engineering or other related fields with 6+ years of experience working in a regulated, cGXP environment.

Preferred Qualifications

• Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation is preferred.
• Clear understanding of cGMP via experience in working in a regulated environment
• Demonstrated knowledge of cGXP regulations and guidance.
• Demonstrated experience with change control, CAPA and deviation quality systems.
• Demonstrated experience with project management

Skills:

• Experience with Trackwise or equivalent system
• Experience with metrics and trending
• Experience with analytical instrumentation
• Experience with Environmental Monitoring and Critical Utilities
• Ability to work independently with minimal supervision and direction
• Ability to function well in a fast paced environment
• High attention to detail and accuracy
• Self-motivated and highly organized
• Experience with project management
• Hands on problem solving and strong analytical skills
• Strong computer skills

Special Working Conditions

• Ability to gown and gain entry to manufacturing and Quality Control areas.

Why Choose Us:

• Bring the miracles of science to life alongside a supportive, future-focused team.

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