Job Opportunity: Site Microbiologist
Are you interested in working in biotech before it reaches full-scale production? This role might be perfect for you.
Our client is a growing biotech company with a strong global presence, currently expanding their facility in Sligo town. Recognized as a great place to work, they are looking for a Site Microbiologist to join their team.
Reporting to the QC Manager, this key position involves overseeing the transition of cleanrooms from Grade D to Grade A classification and managing compliance across all non-Grade A spaces. The ideal candidate will have a solid microbiology background and understanding of risks in a biopharmaceutical EU GMP environment.
For a confidential discussion, contact Deirdre at 01 or send an updated CV.
Role Responsibilities
1. Lead and manage the upgrade of cleanroom environments from Grade D to Grade A.
2. Ensure microbiological practices comply with GMP, Department of Agriculture, Food & Marine, and other relevant regulations.
3. Conduct audits and inspections to maintain cleanliness, sterility, and bioburden control.
4. Design and implement environmental monitoring programs for upgraded cleanrooms.
5. Analyze monitoring data, identify trends, and implement corrective actions.
6. Lead aseptic process simulation (APS) activities in line with Annex 1 guidance.
7. Develop and validate aseptic process simulation protocols and reports.
8. Validate manufacturing equipment, HVAC, and other critical systems in a GMP setting.
9. Draft, review, and update SOPs related to microbiology, cleanroom operations, and monitoring.
10. Provide microbiological training to staff and ensure SOP adherence.
11. Coordinate on-site aseptic processing and gowning training, including requalification programs.
12. Implement contamination control strategies to prevent microbial contamination.
13. Investigate microbiological deviations and non-conformities.
14. Collaborate with Operations, Quality, Engineering, and TSA to ensure microbiological quality.
15. Identify potential environmental, health, and safety hazards and conduct risk assessments.
Minimum Requirements
* Bachelor’s degree in Microbiology, Biotechnology, or equivalent; Master’s degree preferred.
* At least 5 years of experience in a similar role within a biopharmaceutical manufacturing environment, especially with Grade A cleanrooms and aseptic processing.
* Extensive experience in cleanroom validation and qualification.
* Experience managing environmental monitoring programs and cleanroom classification upgrades.
* Knowledge of regulatory inspections and audits.
* Proficiency in MS Office Suite.
#J-18808-Ljbffr