Senior Quality Engineer, Contamination Control

Sanofi • Framingham, MA

387d

About The Position

The Senior Quality Engineer in Contamination Control at Sanofi is responsible for ensuring the quality and safety of manufacturing processes by monitoring contamination controls and maintaining microbiological standards. This role involves assessing environmental controls, investigating microbial excursions, and leading compliance with quality operations standards. The engineer will work closely with various teams to implement strategies that reduce microbial risks and improve overall manufacturing quality.

Requirements

• Masters with 7+ years, Bachelor's with 9+ years, Associate's with 11+ years of experience in Quality Engineering/Assurance/Control and knowledge of cGXP regulations and biologics or similar manufacturing processes.
• Intermediate to advanced computer proficiency, strong verbal and written communication skills.
• Proven investigation skills.
• Experience with quality systems and cGMP data review.
• Demonstrated knowledge of cGXP regulations and guidance.
• Demonstrated experience with change control, CAPA and deviation quality systems.
• Demonstrated proficiency in critical thinking and technical writing.

Nice To Haves

• Masters degree in a scientific field with 9 years of experience in Microbiology.
• Experience in bio-pharmaceutical industry.
• Strong technical writing skills.
• Effective time management, attention to detail, organizational skills, teamwork and collaborations.
• Demonstrated competence in problem solving methodology.
• Experience participating and/or leading cross-functional project team collaborations.

Responsibilities

• Monitor metrics to evaluate effectiveness of contamination controls and continued sustainability.
• Actively participate and prepare information for the Environmental Action Committee (EAC).
• Prepare data for presentation at quarterly management reviews.
• Investigate and assess EM/CU excursions and determine appropriate CAPA.
• Provide trending for EM, and critical utilities monitoring in an accurate and timely manner.
• Write Microbial assessments for bioburden recovery from the product/process.
• Ensure compliance with Sanofi and Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.
• Act as study director for critical utility risk assessments and/or EQ studies.
• Determine sampling plans for utility and HVAC interventions and in process product monitoring and microbial controls (HACCP risk assessments).
• Perform contamination control walk through of clean rooms and utility systems; provide recommendations and track actions.
• Provide guidance to production and facilities on contamination control requirements.
• Be a member of all Site Contamination Control Teams.
• Support the site Contamination Control strategy and plan resulting in reduced microbial risk.
• Support the Contamination Control Community of Practice (CoP) Network and assist in driving network improvements.
• Lead compliance with Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.
• Lead site environmental and viral risk mitigation actions.
• Actively apply continuous improvement and Sanofi Manufacturing System (SMS) tools which improve reliability and capacity while ensuring quality.

Benefits

• High-quality healthcare coverage.
• Prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees