Contamination Control Specialist

Sanofi • Framingham, MA

6d • Onsite

About The Position

The Contamination Control Specialist supports quality and manufacturing activities at Sanofi’s Framingham Biologics Campus through the Sterility Assurance and Microbiology (Contamination Control) Department. The department identifies microbial-contaminant trends that could affect product quality during manufacturing, maintains microbiological control in utility systems and manufacturing environments, assesses personnel aseptic behavior, and helps ensure areas remain under environmental control.

The specialist serves as a subject matter expert in assigned contamination-control areas, conducts risk assessments, oversees relevant site activities and systems, investigates contamination-control failures, and recommends corrective and preventive actions. The role collaborates with cross-functional teams, maintains a visible shop-floor presence to assess practices and document observations, reviews monitoring data and trends, and contributes expertise during audits and regulatory inspections. It also supports validation protocols, related projects, quality documentation, and the adoption of best practices shared by global functions.

The position requires experience in sterility assurance, microbiology, or contamination control in a pharmaceutical or biotechnology environment, along with knowledge of cGXP regulations, GMP, and quality systems. The role 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 at least 8 years of experience in a regulated cGXP environment; or a master’s degree in one of these fields and at least 6 years of such experience.
• Experience in sterility assurance, microbiology, or contamination control in a pharmaceutical or biotechnology environment.
• Ability to review documentation, processes, and products meticulously for compliance with Sanofi GOP and Quality standards.
• Knowledge of regulatory requirements and Good Manufacturing Practices relevant to sterility assurance and microbiological control.
• Communication skills to work with functions from the shop floor to management and present complex subjects.
• Ability to organize and lead routine investigations with multidisciplinary teams.
• 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.
• 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 ability 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 the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.

Responsibilities

• Serve as the subject matter expert for assigned topics within the Contamination Control SOP.
• Conduct contamination-control risk assessments.
• 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.
• Document shop-floor observations, inform management, and provide feedback to operators.
• Review contamination-control monitoring data and trends and propose improvements.
• 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 Centers of Excellence or Communities of Practice and implement shared best practices on site.
• Advise on contamination-control protocols and procedures and recommend improvements to cross-functional teams.
• Contribute to quality documentation, SOPs, and validation protocols.
• Organize and lead routine investigations with multidisciplinary teams.

Benefits

• At least 14 weeks of gender-neutral parental leave.
• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• Employee benefit programs; eligibility may apply.
• Opportunities for career growth through promotion or lateral moves, domestically or internationally.
• A rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior