Contamination Control Specialist – GMP & Microbiology

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

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.