Our client's Microbiology Department, part of their Quality Assurance team, is seeking a dynamic and skilled Microbiologist II (onsite role) to support the start-up of their first European manufacturing facility in Galway.
In this role, you will be responsible for ensuring compliance with domestic and international standards in relation to the day-to-day operation of the Microbiology laboratory, environmental monitoring (e.g., HVAC/cleanroom, compressed air, water), product testing, medical device sterilisation, equipment qualification, implementation and use of LIMS, and the training of laboratory personnel.
Where you come in:
You will support the establishment of the Microbiology Department and its laboratory function, developing and creating protocols to support Microbiology Test Method Validations, Cleanroom Performance Qualification, Equipment Qualification, Process Cleaning and Disinfectant Qualifications, and generating corresponding qualification reports.
You will work within the Microbiology team and alongside the contract laboratory to support, execute and complete all microbiology activities according to defined schedules, company procedures, and current domestic and international standards to ensure regulatory compliance.
You will review, interpret and approve laboratory test results, and contribute to the preparation of periodic microbial testing reports (e.g., monthly/quarterly/annual EM, Product Bioburden, and Product Endotoxin).
You will support the creation and review of microbiology procedures and documentation, ensuring accuracy and completeness, and will create and execute Experimental Requests to support special studies and projects.
You will assess changes to cleanroom environments by supporting the Equipment Transfer Plan programme, performing risk assessments related to the manufacturing process, product development and product changes, and coordinating facility, equipment and HVAC maintenance across multiple departments.
You will coordinate and support activities associated with laboratory deviations, OOS events, CAPAs, NCMRs and COPs, and maintain environmental monitoring excursion communication, reporting, investigation, disposition and corrective action processes.
You will be responsible for qualification, calibration and routine maintenance of laboratory equipment and associated records, as well as supporting the implementation and use of a laboratory LIMS system.
You will support additional tasks related to the general operation of the laboratory and undertake further responsibilities as required by management.
What makes you successful:
A bachelor's degree in Microbiology, Biology or an equivalent scientific discipline.
3–5 years' microbiology experience within the medical device, biopharmaceutical, pharmaceutical or similar industry.
Knowledge and understanding of relevant standards and regulations (e.g., 21 CFR 820, ISO *****, US and EU Pharmacopeia,, AAMI/TIR 52, ISO *****, *****, *****, EN
Desirable knowledge of environmental monitoring systems (HVAC, cleanrooms, compressed air, compressed gases, water), cleanroom microbiology and product sterilisation.
Experience in establishing a microbiology department or laboratory function, conducting test method validations and equipment qualifications is advantageous.
Strong communication and cross-functional collaboration skills, with the ability to self-motivate and drive projects to completion.
What you'll get:
The opportunity to contribute to life-changing medical technology and be part of an innovative, industry-leading organisation committed to its employees, customers and the communities it serves.
A full and comprehensive benefits programme.
Global growth and development opportunities.
Access to career development through in-house learning programmes and/or approved tuition reimbursement.
Travel Required:
Approximately 5%