Site Microbiologist

Excellent opportunity for a Site Microbiologist to join a global biologics company in the west of Ireland. Reporting to the QC Manager, this key role oversees the upgrade of cleanrooms from Grade D to Grade A, ensuring regulatory compliance. The Site Microbiologist also manages classification of all non-Grade A areas. A strong self-starter with expert knowledge of microbiology and biopharmaceutical GMP is essential.

Overview of your responsibilities

- Lead cleanroom upgrades from Grade D to Grade A.
- Develop action plans covering timelines, resources, costs, and risks.
- Ensure GMP and regulatory compliance.
- Conduct audits to maintain cleanliness and sterility.
- Implement environmental monitoring for upgraded cleanrooms.
- Analyse data and address issues.
- Lead aseptic process simulation (APS) qualifications.
- Develop APS validation protocols and reports.
- Experience in equipment, HVAC, and critical system validation in GMP.

Knowledge, Skills and Experience Required for the Role:

- 5+ years' experience, ideally in biopharmaceuticals (Grade A cleanroom/aseptic processing preferred).
- Extensive cleanroom validation and qualification experience.
- Proven management of environmental monitoring programs.
- Cleanroom upgrade experience desirable.
- Experience with regulatory and client inspections/audits.

For a confidential discussion and more information on the role, contact Courtney Russell.

Email: courtney.russell@collinsmcnicholas.ie

Phone: +353 (0) 71 9108062

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