What are the responsibilities and job description for the Senior Quality Engineer, Contamination Control position at Sanofi?
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
Preferred Qualifications
Special Working Conditions
Why Choose Us?
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.
GD-SG
LI-GZ
LI-Onsite
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.
