Job Information
Sanofi Group Principal Quality Engineer – Quality Assurance Contamination Control in Framingham, Massachusetts
Job Title: Principal Quality Engineer – Quality Assurance Contamination Control
Location : Framingham, MA
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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Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)