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