Sterility Assurance Specialist

Location: Waterford, Ireland
Job Type: One‑year fixed‑term contract (maternity cover)
Work Arrangement: Hybrid – 3 days per week on-site, and 2 days home-office

About the job

As a Sterility Assurance Specialist, you will be responsible for developing, implementing, and maintaining sterility assurance programs to ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. You will function as the subject matter expert (SME) for aseptic processing, contamination control, and microbiological quality, supporting manufacturing operations, quality systems, and continuous improvement initiatives.

Ready to get started?

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. Our Waterford site is a key part of this network, and your work here will directly contribute to ensuring the safety and quality of the medicines and vaccines we deliver to patients around the world.

Main responsibilities:

Develop and maintain site sterility assurance strategies, contamination control plans, and ensure compliance with EU GMP Annex 1, FDA, and ISO standards.
Lead risk assessments for aseptic processes, cleanroom operations, and sterilisation activities; provide SME oversight during media fills and environmental monitoring.
Support deviation investigations, root cause analysis, and CAPA implementation for sterility-related issues, identifying trends and implementing corrective actions.
Review and approve protocols, reports, and documentation for sterilisation validation, cleanroom qualification, disinfection studies, and aseptic manufacturing controls.
Serve as point of contact for sterility assurance during internal/external audits and regulatory inspections, ensuring timely risk identification and communication.
Establish and monitor KPIs for the sterility assurance program; drive improvements in aseptic practices, gowning, cleaning, and contamination control procedures.
Deliver training to manufacturing, QC, and QA teams on sterility principles; monitor emerging regulatory changes and industry best practices to update site procedures.

About you

Bachelor’s degree (or higher) in Microbiology, Biology, Pharmacy, or a related scientific field.
Extensive experience in sterility assurance, microbiology, or quality assurance within GMP‑regulated manufacturing.
Strong aseptic expertise, including contamination control strategy, aseptic process validation, and knowledge of sterilisation methods (autoclave, VHP, gamma irradiation).
Proven success in regulatory inspections and strong understanding of GMP quality and technical regulations.
Ability to analyse complex microbiological data, including environmental monitoring trends.
Excellent communication and leadership skills, with the ability to influence cross‑functional teams and make decisions under pressure.
Strong problem‑solving skills and ability to perform effectively in high‑stakes operational environments.

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.
Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

#LI-EUR

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!

Sterility Assurance Specialist

Job Description