Senior Quality Engineer, Contamination Control

Job Title : Senior Quality Engineer, 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 :

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.

Writes Microbial assessments for bioburden recovery from the product / process.

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

Acts as study director for critical utility risk assessments and / or EQ studies

Determines 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 ot production and facilities on contamination control requirements.

Member of all Site Contamination Control Teams

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

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 applies continuous improvement and Sanofi Manufacturing System (SMS) tools which improve reliability and capacity while ensuring quality.

About You

Basic Qualifications

Basic : Masters with 7 years, Bachelor’s with 9 years, Associate’s with 11 years, 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.

Preferred Qualifications

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.

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 () and check out our Diversity Equity and Inclusion actions at sanofi.com () !

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 ()

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 ()