Principal Microbiologist – Pharma - Contract
Be Part of Something Groundbreaking
About the Role
This is a unique opportunity to join a world-class team at a pivotal moment as we launch the first pharmaceutical product at a cutting-edge facility in Cork.
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.
Requirements:
* 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.