**Job Title** : Sterility assurance and microbiology specialist **Location** : Swiftwater, PA **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. Advise on sterility assurance & microbiological protocols and procedures Propose corrective and preventive actions to improve contamination controls Advise cross-functional teams on best practices or expected improvements in her/his area of expertise Presence on the shopfloor with formal traceability of the observations; Inform management and feedback operators 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:** + Leading as SME specific subjects part of the Contamination Control SOP in her/hisarea of expertise + Conducting risk assessments related to contamination control + Overseeing site activities and performance for contamination control systems in her/his scope of responsibilities + Leading investigation following contamination control failures and propose correctiveand preventive actions (CAPA) + Collaborating with cross-functional teams to ensure product quality + Ensure presence on the shop floor to oversee practices, identify gaps vs SOP forcontamination control + Reviewing data from contamination control monitoring to propose improvements asnecessary (from monitoring and trends) + Participating in audits and regulatory inspections and audits, providing expertise onsterility assurance and microbiology + Supporting the preparation of validation protocol and support project related to her/hisarea of expertise + Contributing as an SME to specific CoE/CoP with Global functions; implementing onsite the best practices shared + Subject Matter Expert for Traffic and Gowning as well as Cleaning and Disinfection. + Mentor other team members and present and defend materials during audits. + Author and update departmental documents as well as any other protocols, reports, procedures, and training materials, as needed to ensure departmental compliance with site, global, and regulatory requirements. + Final signatory approver of program documents including but not limited to procedures, reports, and excursion investigations. **About You** **EDUCATION/EXPERIENCE:** + BS in Microbiology, Engineering, or other relevant technical field. +5 years’ experience in a cGMP controlled industry (i.e.: pharmaceutical/vaccine) including knowledge of cGMPs and regulatory requirements. + Experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment + Communication skills to communicate with a large number of functions (fromshopfloor to management) and to present complex subjects + Ability to organize and lead routine investigations with a multi-disciplinary team **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. \#GD-SP ​ \#LI-SP \#LI-Onsite \#vhd **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. _North America Applicants Only_ The salary range for this position is: $84,750.00 - $122,416.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) 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)