Job Description

Job Description

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/his

  area 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 corrective

  and 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 for

  contamination control

• Reviewing data from contamination control monitoring to propose improvements as

  necessary (from monitoring and trends)

• Participating in audits and regulatory inspections and audits, providing expertise on

  sterility assurance and microbiology

• Supporting the preparation of validation protocol and support project related to her/his

  area of expertise

• Contributing as an SME to specific CoE/CoP with Global functions; implementing on

  site 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 (from

  shopfloor 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

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Job Tags

Similar Jobs