Bachelor's or Master's degree in Life Sciences, Engineering, or related fields with 6-8 years of experience in a regulated cGXP environment.
Experience in sterility assurance and contamination control within pharmaceuticals or biotechnology.
In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP).
Strong communication skills for interaction across various functions and levels.
Ability to lead investigations with a multi-disciplinary team.
Responsibilities
Lead as a Subject Matter Expert (SME) on contamination control SOPs.
Conduct risk assessments related to contamination control.
Oversee contamination control systems and site activities.
Investigate contamination control failures and propose corrective actions.
Collaborate with cross-functional teams to ensure product quality.
Monitor shop floor practices and identify gaps in SOP compliance.
Review contamination control monitoring data to suggest improvements.
Benefits
Supportive, future-focused team environment.
Opportunities for career growth and international mobility.
Comprehensive health and wellbeing benefits, including high-quality healthcare and parental leave.
Access to cutting-edge technology in medicine and vaccine delivery.
Engagement in digital and AI-driven innovation to enhance performance.
Full Job Description
Job Title: Contamination Control Specialist Location: Framingham, MA
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.
Clear understanding of cGMP via experience in working in a regulated environment
Demonstrated knowledge of cGXP regulations and guidance.
Demonstrated experience with change control, CAPA and deviation quality systems.
Demonstrated experience with project management
Skills:
Experience with Trackwise or 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 well in a fast paced environment
High attention to detail and accuracy
Self-motivated and highly organized
Experience with project management
Hands on problem solving and strong analytical skills
Strong computer skills
Special Working Conditions
Ability to gown and gain entry to manufacturing and Quality Control 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.
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale.
Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is: $113.250,00 - $163.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
About Sanofi
Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
