Principal Quality Engineer – Quality Assurance Contamination Control

Job Title: Principal Quality Engineer – Quality Assurance Contamination Control

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities 

• Supports the execution of the 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 insure risk reduction 

• Actively participate part in the Environmental Action Committee (EAC) 

• Participate in presenting 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 

• Ensures 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

• Member of all Site Contamination Control Teams 

• Actively involved in system design decision making and team meetings

• Ensures systems are simple, sustainable, robust and compliant 

• Key participant in working to resolve issues to the Site Contamination Control Lead 

• Execute environmental monitoring (EM) risk assessments and/or EQ studies to the CC site lead, Quality Assurance, the Environmental Action Committee (EAC) and senior leadership. 

• Actively support work plans with other contamination control teams throughout Sanofi 

• Work with the Facilities and Equipment Project Upgrade Team to discuss the results of facility walkthroughs for installation and relocation of critical utility sampling sites 

• Build consensus, across functional areas and obtain stakeholder agreement for contamination control improvements and continued 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 and continued sustainability 

• Work with the Viral Assessment Risk Management team to insure risk reduction

• 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 

• Ensures compliance with Sanofi Corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring 

• Provides leadership in conducting microbiologic risk assessments (including viral biosafety) pertaining to contamination control 

• Support site biosafety improvements and high-risk mitigation actions 

• Actively evaluates and ensures alignment of Site Contamination Control program with evolving industry, regulatory and compendia trends and information 

• Actively applies continuous improvement and Sanofi Manufacturing System 

• (SMS) tools which improve reliability and capacity while ensuring quality

About You

Basic Qualifications

• Bachelor's degree in Science or Engineering and a minimum of 9 years experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years experience working in a regulated, cGXP environment. 

• Operations experience in one or more of the following areas: 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

Preferred Qualifications

• Clear understanding of cGMP via experience in working 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 

• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. 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.

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