Contamination Control Specialist
About The Position
The Sterility Assurance and Microbiology (Contamination Control) Department supports quality and manufacturing activities at Sanofi’s Framingham Biologics Campus. It identifies potential trends in microbial contaminants that could affect product quality at different manufacturing stages, maintains microbiological control in utility systems and manufacturing environments, assesses personnel aseptic behavior, and helps ensure areas remain under environmental control. The Contamination Control Specialist serves as a subject-matter expert for contamination control within their area of expertise. The role oversees contamination control systems and site activities, assesses risks, leads investigations and recommends corrective and preventive actions, reviews monitoring data and trends, and advises teams on procedures and best practices. The specialist works with cross-functional partners, maintains a presence on the shop floor, contributes to quality documentation and validation protocols, and supports audits, regulatory inspections, and related projects. The position is based in Framingham, Massachusetts, and requires the ability to gown and enter manufacturing and Quality Control areas.
Requirements
- Bachelor’s degree in Life Sciences, Sciences, Engineering, or a related field and 8 or more years of experience in a regulated cGXP environment; alternatively, a master’s degree in one of these fields and 6 or more years of experience in a regulated cGXP environment.
- Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment.
- Ability to review and analyze documentation, processes, and products for compliance with Sanofi GOP and 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 functions from the shop floor to management and present complex subjects.
- Ability to work independently with minimal supervision and direction.
- Ability to function in a fast-paced environment.
- High attention to detail and accuracy; self-motivated and highly organized.
- Hands-on problem-solving and strong analytical skills.
- Strong computer skills.
- Ability to gown and gain entry to manufacturing and Quality Control areas.
Nice To Haves
- Operations experience in one or more of Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
- Clear understanding of cGMP gained through work in a regulated environment.
- Demonstrated knowledge of cGXP regulations and guidance.
- Demonstrated experience with change control, CAPA, and deviation quality systems.
- Experience with project management.
- Experience with Trackwise or an equivalent system.
- Experience with metrics and trending.
- Experience with analytical instrumentation.
- Experience with Environmental Monitoring and Critical Utilities.
Responsibilities
- Serve as a subject-matter expert for specific topics in the Contamination Control SOP within the assigned area of expertise.
- Conduct risk assessments related to contamination control.
- Oversee site activities and performance for contamination control systems within the assigned scope.
- Lead investigations following contamination control failures and propose corrective and preventive actions (CAPA).
- Collaborate with cross-functional teams to ensure product quality.
- Maintain a shop-floor presence to oversee practices and identify gaps against contamination control SOPs.
- Review contamination control monitoring data and trends and propose improvements as needed.
- Participate in audits and regulatory inspections, providing contamination control expertise.
- Support preparation of validation protocols and projects related to the area of expertise.
- Contribute as a subject-matter expert to Global Center of Excellence or Community of Practice activities and implement shared best practices on site.
- Advise on contamination control protocols and procedures.
- Advise cross-functional teams on best practices and expected improvements within the area of expertise.
- Document shop-floor observations, inform management, and provide feedback to operators.
- Contribute to quality documentation, SOPs, and validation protocols.
- Organize and lead routine investigations with multidisciplinary teams.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Company employee benefit programs may be available to eligible employees.
- Rewards package recognizing employee contributions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
