Sterility Assurance Specialist

• Location: Waterford, Ireland
• Fixed Term Contract

About Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

The Sterility Assurance Specialist will be responsible for developing, implementing, and maintaining sterility assurance programs to ensure compliance with Good Manufacturing Practice (GMP) and regulatory requirements. This role 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.

Main responsibilities:

• Develop, maintain, and improve site sterility assurance strategies and contamination control plans.
• Lead risk assessments for aseptic processes, cleanroom operations, and sterilisation activities.
• Ensure compliance with relevant guidelines (e.g., EU GMP Annex 1, FDA Guidance for Industry, ISO standards).
• Provide SME oversight during aseptic processing, media fills, and environmental monitoring trend reviews. Identifying trends or issues and implementing effective action plans.
• Support deviation investigations, root cause analysis, and CAPA implementation for sterility-related issues.
• Review and approve protocols and reports for sterilisation validation, cleanroom qualification, and disinfection studies.
• Review and approve documentation related to aseptic manufacturing, sterilisation, and microbiological controls.
• Function as point of contact for sterility assurance during internal and external audits and regulatory inspections.
• Ensure timely identification and communication of sterility-related risks.
• Establish and monitor KPIs for the sterility assurance program and report on its performance and effectiveness.
• Drive improvements in aseptic practices, gowning, cleaning, and contamination control procedures.
• Deliver training and coaching to manufacturing, QC, and QA teams on sterility assurance principles.
• Monitor emerging regulatory changes and industry best practices to update site procedures accordingly.

• Bachelor's degree (or higher) in Microbiology, Biology, Pharmacy, or related scientific discipline.
• Extensive experience in sterility assurance, microbiology, or quality assurance within GMP-regulated manufacturing.
• Experience leading contamination control strategies and aseptic process validations.
• Demonstrated track record of successful regulatory inspections.
• Sterilisation validation experience (e.g., autoclave, VHP, gamma irradiation) desirable.
• Strong knowledge of aseptic manufacturing, microbiology, sterilisation methods, and cleanroom operations.
• In-depth understanding of quality and technical regulations in a GMP environment.
• Analytical mindset with ability to interpret complex microbiological data and environmental monitoring trends.
• Excellent communication and leadership skills to influence cross-functional teams.
• Strong problem-solving skills and ability to make decisions under pressure.

• 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.

We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.
If you have a disability and require adjustments for the interview process, please email us at . We are dedicated to ensuring an inclusive and supportive experience for all applicants.