Senior Microbiologist

Senior Microbiologist - 12 Month Fixed Term Contract

We are seeking an experienced Microbiology / Sterilization professional to join our client's South Dublin manufacturing site, where quality, compliance, and patient safety are paramount.

In this role, you will be the site subject-matter expert for microbiology, ETO sterilization, GLP, and cleanroom standards, ensuring all products are manufactured in full compliance with regulatory and company requirements.

You will provide hands-on technical expertise, partner closely with Quality and Manufacturing teams, and play a critical role in maintaining the site in a continuous state of inspection readiness.

This is an excellent opportunity for a senior microbiology professional who enjoys working in a regulated manufacturing environment, influencing quality outcomes, and ensuring the highest standards are consistently met throughout the duration of the contract.

This is a fully onsite role due to the hands-on nature of laboratory and cleanroom activities.

Key responsibilities:

· SME oversight for EtO sterilization, requalification, GLP labs, and environmental monitoring

· Review/approve sterilization cycles, microbiological data, and product release

· Set appropriate microbiological and sterilization quality standards for products and ensure consistent application

· Ensure compliance with ISO 11135, ISO 10993, ISO 13485, FDA QSR/QMSR

· Lead and support investigations, CAPA, and non-conformance resolution

· Maintain laboratory safety, equipment readiness, and compliance with data integrity expectations.

· Maintain audit and inspection readiness

Profile:

· Degree in Microbiology or related Science

· 5+ years’ experience in medical device, pharma, or biotech

· Strong expertise in GLP, cleanrooms, validation, and sterilization

· EtO sterilization experience advantageous

· Proven ability to work cross-functionally in regulated environments