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 (full job description available on request)
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
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062