Sterility Assurance Lead, Contamination Control
Sanofi
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Job summary
Sanofi Framingham is seeking a Contamination Control Specialist to ensure sterility and environmental control across manufacturing environments. You will act as SME for contamination control, conduct risk assessments, lead investigations, and drive CAPAs while collaborating with cross-functional teams to uphold product quality.
You will participate in audits and validations, maintain shop-floor oversight, and apply GMP knowledge to keep facilities in a state of environmental control and
Qualifications
- Bachelor's or Master’s in Life Sciences, Engineering or related field with regulated experience.
- Experience in sterility assurance and microbiological control in pharma/biotech.
- Strong knowledge of GMP and cGXP requirements.
Responsibilities
- Lead SME activities within Contamination Control SOP and area of expertise.
- Conduct risk assessments related to contamination control.
- Oversee site activities and performance for contamination control systems.
- Lead investigations for contamination control failures and CAPA.
- Collaborate with cross-functional teams to ensure product quality.
- Maintain shop floor presence to identify gaps vs SOP and document observations.
- Review contamination control data and trends to drive improvements.
- Participate in audits and regulatory inspections as contamination control expert.
- Assist in validation protocol preparation and related projects.
Skills
Education
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Job description
Sanofi Framingham is seeking a Contamination Control Specialist to ensure sterility and environmental control across manufacturing environments. You will act as SME for contamination control, conduct risk assessments, lead investigations, and drive CAPAs while collaborating with cross-functional teams to uphold product quality.
You will participate in audits and validations, maintain shop-floor oversight, and apply GMP knowledge to keep facilities in a state of environmental control and
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