Principal Microbiologist – Pharma - Contract
Be Part of Something Groundbreaking!
Are you an experienced microbiologist with a background in pharma, Annex 1, and contamination control? Do you want to play a key role in launching the first pharmaceutical product at a cutting-edge facility in Cork? If so, we want to hear from you!
This is a unique opportunity to join a world-class team at a pivotal moment. As a Principal Microbiologist, you will be instrumental in ensuring the highest microbiological standards and contamination control in an exciting new pharmaceutical manufacturing environment.
Your Impact:
1. Lead the implementation and maintenance of the Contamination Control Strategy, ensuring compliance with Annex 1 guidelines.
2. Act as a Subject Matter Expert (SME) on bio-decontamination, partnering with Operations to enhance contamination prevention and control.
3. Identify and drive process improvements to optimize microbiological methods and contamination control.
4. Provide hands-on support and training on cleanroom behaviors, aseptic processing, and best practices.
5. Troubleshoot and investigate contamination events, including Bioburden, Sterility, Environmental Monitoring, and Utilities.
6. Manage Change Controls, Investigations, Deviations, and Quality Risk Management processes.
7. Support and prepare for Regulatory Audits, ensuring compliance with GxP standards.
8. Collaborate cross-functionally with teams including Operations, QA, Validation, and Facilities to drive excellence.
9. Coach and develop individuals within the microbiology team, fostering a high-performance culture.
What You Bring:
1. A third-level relevant degree in Microbiology, Biotechnology, or a related field.
2. At least 4 years of experience in the pharmaceutical industry or another highly regulated industry such as medical devices or biotechnology.
3. Pharma background with proven experience in Annex 1 and contamination control.
4. Strong technical expertise in microbiology, environmental monitoring, and aseptic processing.
5. Experience in leading projects, troubleshooting microbiological issues, and optimizing methods.
6. Excellent technical writing skills, including SOPs, QRAs, and investigation reports.
7. Strong communication and collaboration skills – ability to work effectively across teams.
Why Join Us?
1. Work on an innovative new pharma product – the first of its kind at this facility!
2. Be a key player in establishing best-in-class contamination control and risk assessment strategies.
3. Collaborate with top-tier professionals in Operations, Quality, and Validation.
For a confidential discussion and more information on the role, please contact Aisling Lane.
Email: aisling.lane@collinsmcnicholas.ie
Phone: (021) 4320675
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