Contamination Control Specialist

BioSpace; Framingham (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

High-quality healthcare

Gender-neutral parental leave (14+ wks

Job summary

Sanofi Framingham Biologics Campus seeks a Contamination Control Specialist to lead SOPs and risk assessments in sterility assurance. You will oversee environmental monitoring, perform investigations, and drive CAPA with cross-functional teams to ensure product quality.

This role emphasizes shop-floor presence and regulatory compliance. Qualified candidates hold a life sciences or engineering degree with cGXP experience, familiarity with Trackwise, and strong data analysis skills.

Qualifications

• Bachelor's or master's degree in Life Sciences or Engineering with regulated, cGXP experience.
• Experience in sterility assurance within pharma/biotech.
• Knowledge of cGMP and cGXP regulations.
• Experience with CAPA, change control and deviation systems.
• Strong analytical and documentation skills.

Responsibilities

• Lead contamination control SOPs and risk assessments.
• Oversee contamination control systems and shop-floor practices.
• Lead investigations and CAPA for contamination events.
• Collaborate with cross-functional teams to ensure product quality.
• Support validation protocols and related projects.

Skills

Sterility assurance

Environmental Monitoring

CAPA

Regulatory knowledge (GMP/cGXP)

Data analysis & trending

Project management

Traceability systems

Education

Bachelor's degree in Life Sciences/Engineering

Master's degree in Life Sciences/Engineering

Tools

Trackwise

Analytical instrumentation

Job description

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

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples 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+ yearsexperience 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.

PreferredQualifications

Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, orAutomation is preferred.

Clear understanding of cGMP via experience in working in a regulatedenvironment

Demonstrated knowledge of cGXP regulations and guidance.

Demonstrated experience with change control, CAPA and deviation qualitysystems.

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 WorkingConditions

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 its 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff1. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

#vhd

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.