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.
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