Principal Quality Engineer - Quality Assurance Contamination Control

Sanofi - Framingham, MA

Full-time - Principal

Framingham, MA

Chemical Manufacturing

About the position

The Principal Quality Engineer in the Quality Assurance Contamination Control department at Sanofi is responsible for ensuring microbiological control in the manufacturing environment. This role involves executing environmental monitoring risk assessments, supporting contamination control strategies, and ensuring compliance with quality standards. The position plays a critical role in maintaining product quality and safety by assessing microbial risks and participating in continuous improvement initiatives.

Responsibilities

• Support the execution of environmental monitoring (EM) risk assessments and/or EQ studies to the CC site lead.
• Monitor metrics to evaluate effectiveness of contamination controls and continued sustainability.
• Support Viral Assessments to ensure risk reduction.
• Actively participate in the Environmental Action Committee (EAC).
• Present EM/CU results at quarterly management reviews.
• Investigate and assess EM/CU excursions.
• Provide trending for EM and critical utilities monitoring in an accurate and timely manner.
• Ensure compliance with Sanofi and Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.
• Support microbiological risk assessments (including viral biosafety) pertaining to contamination control.
• Actively involved in system design decision making and team meetings.
• Ensure systems are simple, sustainable, robust, and compliant.
• Execute environmental monitoring (EM) risk assessments and/or EQ studies to the CC site lead, Quality Assurance, the EAC, and senior leadership.
• Support work plans with other contamination control teams throughout Sanofi.
• Discuss results of facility walkthroughs for installation and relocation of critical utility sampling sites with the Facilities and Equipment Project Upgrade Team.
• Build consensus across functional areas for contamination control improvements and sustainability.
• Support the site Contamination Control strategy and plan resulting in reduced microbial risk.
• Monitor revised processes and metrics to evaluate effectiveness of contamination controls.
• Assist in management of the Environmental Action Committee (EAC).
• Communicate to senior management on all issues relating to contamination control, viral, and biosafety issues.
• Investigate and assess the impact following microbiologic excursions.
• Support site viral and biosafety related investigations.
• Ensure biosafety projects prioritization and visibility.
• Support the Contamination Control Community of Practice (CoP) Network and assist in driving network improvements.
• Ensure that all relevant trending for EM, bioburden, and critical utilities monitoring is accurate, timely, and actionable.
• Provide leadership in conducting microbiologic risk assessments (including viral biosafety) pertaining to contamination control.
• Support site biosafety improvements and high-risk mitigation actions.
• Evaluate and ensure alignment of Site Contamination Control program with evolving industry, regulatory, and compendia trends and information.
• Apply continuous improvement and Sanofi Manufacturing System (SMS) tools to improve reliability and capacity while ensuring quality.

Requirements

• Bachelor's degree in Science or Engineering and a minimum of 9 years experience in a regulated, cGXP environment, or a Master's degree and a minimum of 6 years experience in a regulated, cGXP environment.
• Operations experience in Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
• Demonstrated knowledge of cGXP regulations and guidance.
• Demonstrated experience with change control, CAPA, and deviation quality systems.
• Demonstrated experience with project management.

Nice-to-haves

• Clear understanding of cGMP via experience in a regulated environment.
• 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.
• Hands-on problem solving and strong analytical skills.
• Strong computer skills.

Benefits

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