Microbiologist II (Contractor - 6 Month Term)
We are seeking a Microbiologist II to support the startup of our first European manufacturing facility in Galway. The role is a 6‑month contractor position, onsite.
Responsibilities
* Set up the Microbiology Department and laboratory function, developing protocols to support Microbiology Test Method Validations, Cleanroom Performance Qualification, Equipment Qualification, Process Cleaning and Disinfectant Qualifications, and generate qualification reports.
* Work within the Microbiology team and contract laboratory, executing all microscopic activities per schedules and in line with company procedures and regulatory standards.
* Review, interpret and approve laboratory test results; prepare periodic microbial testing reports (monthly/quarterly/annual EM, Product Bioburden, Product Endotoxin).
* Support creation and review of Microbiology procedures and documents; execute Experimental Requests for special studies and projects.
* Assess cleanroom environment changes, support Equipment Transfer Plan program, perform risk assessments for manufacturing and product changes, coordinate facility, equipment and HVAC maintenance.
* Coordinate laboratory deviations, OOS events, CAPAs, NCMRs, COPs; maintain environmental monitoring excursion communication, reporting, investigation, disposition and corrective action.
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* Qualify, calibrate and maintain laboratory equipment and records; support implementation and use of a laboratory LIMS system.
* Perform additional general laboratory operations as requested by management.
Qualifications
* Bachelor’s degree in Microbiology, Biology or equivalent Science discipline.
* 3‑5 years of microbiology experience in medical device, biopharmaceutical or pharmaceutical industry.
* Knowledge of 21 CFR 820, ISO 13485, US and EU Pharmacopeia, AAMI/TIR 52, ISO 14644, ISO 11737, ISO 14971, EN 17141.
* Experience in monitoring environmental systems (HVAC, cleanroom, compressed air, water), cleanroom microbiology and product sterilization desirable.
* Experience setting up a Microbiology Department/laboratory, test method validations and equipment qualifications an advantage.
* Strong communication and cross‑functional collaboration skills; self‑motivated; capable of driving projects to completion.
Employment
Contract – 6 month term; onsite in Galway, County Galway, Ireland.
For more information, contact Tom Devaney at 091‑758771 or email tdevaney@careerwise.ie.
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