Sterility Assurance Lead – Galway (On-Site)

Are you passionate about contamination control, aseptic excellence, and protecting patient safety? Do you enjoy leading improvements, strengthening processes, and working closely with cross-functional teams to elevate quality standards? If so, this role offers the chance to make a meaningful impact every single day.

We are seeking a Sterility Assurance Lead to join our growing team in Galway, supporting a sterile injectable manufacturing site with a strong and diverse microbiology function. This is a senior, hands-on role where your expertise will directly shape the site’s contamination control strategy and sterility assurance programs.

If you’re looking for a position that values depth of knowledge, collaboration, and continuous improvement, this may be your next step.

What You’ll Do

In this role, you will be the driving force behind sterility assurance and contamination control on site. Your responsibilities will include:

Lead Contamination Control Strategy

• Develop and refine contamination control approaches for sterile manufacturing.
• Guide and mentor microbiology team members in best practices for aseptic operations.
• Bring forward fresh ideas to continually strengthen sterility assurance systems.

Elevate Aseptic & Environmental Monitoring Programs

• Oversee environmental monitoring processes to ensure they effectively support aseptic manufacturing.
• Investigate deviations, trends, and OOS results to identify true root causes and implement meaningful corrective actions.
• Support media fills, sterility test method validation, and aseptic process validations.

Strengthen Compliance & Quality

• Collaborate closely with QA on documentation, audit readiness, and sterility/contamination-related compliance activities.
• Prepare and maintain SOPs, validation documentation, risk assessments, and sterility assurance reports.
• Represent the sterility assurance function during internal and external audits.

Contribute to a Growing, Diverse Team

• Work with an international and collaborative microbiology and quality team.
• Support junior team members and contribute to building a culture of scientific excellence and operational discipline.
• Partner cross-functionally with Manufacturing, Engineering, and Quality to ensure sterility requirements are understood and upheld.

What We’re Looking For

This role is ideal for someone who brings strong microbiology expertise plus the ability to think strategically about contamination control and compliance.

You’ll be a great fit if you have:

• Extensive experience in microbiology, sterile manufacturing, and contamination control.
• A strong grasp of aseptic technique, environmental monitoring, and sterility assurance principles.
• Experience with audits, documentation, investigations, CAPAs, and regulatory expectations (Annex I, GMP, etc.).
• The ability to influence, coach, and collaborate across teams.
• A mindset centered on continuous improvement, problem-solving, and scientific rigor.

If you’re excited by the idea of driving sterility assurance strategy, not just maintaining day-to-day lab operations, you’ll thrive here.

Why This Role Matters

You won’t just be maintaining systems, you’ll be shaping them. Your expertise will directly protect patients, elevate operational excellence, and contribute to the long-term success of sterile manufacturing at the site. This role also offers the opportunity to grow into assistant manager level depending on experience, with future potential for leadership responsibilities.

Work Arrangement

• Full-time, on-site in Galway
• Monday through Friday, standard business hours
• Open to candidates in Ireland, across the EU, and internationally (visa sponsorship available for the right candidate)

Ready to Make an Impact?

If you’re driven by science, motivated by high standards, and energized by solving complex contamination challenges, we’d love to speak with you.

Apply now or reach out for a confidential conversation. [email protected]

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