Contamination Control Engineer - GMP

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* Job Title:

** Contamination Control Specialist
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* Location:

** Framingham, MA
** About the Job
** Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  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.
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* Main Responsibilities:

*** Leading as SME for specific subjects as part of the Contamination Control SOP
* 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 Involvement in Decision Making Process (D=Decision, A=Advisor, I=Informed)
*** Advise on contamination control protocols and procedures (A)
* Propose corrective and preventive actions to improve contamination controls (D)
* Advise cross-functional teams on best practices or expected improvements in her/his area of expertise (A)
* Presence on the shopfloor with formal traceability of the observations. Inform management and feedback operators (A)
* Contribute to quality documentation SOP and validation protocol
** About You
**** Expected Experience
*** Bachelor's degree in Science or Engineering and a minimum of 6 years’ experience working in a regulated, cGXP environment or Master's degree and a minimum of 3 years' experience working in a regulated, cGXP environment.
* Operations experience in one or more of the following areas:
Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
* Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
** Expected Technical Skills
*** 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
** Special Working Conditions
*** Ability to gown and gain entry to controlled, classified areas
** Why Choose Us
*** Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will…