Microbiologist - South Dublin

Microbiologist - South Dublin.

Our client seeks to hire a Senior Microbiologist. In this role, you will play a pivotal part in ensuring that products meet the highest regulatory and company standards. You will coordinate a team of operators and technicians within the Quality Control Laboratory, ensuring compliance with Microbiology standards GLP, and cleanroom requirements. You will also drive root cause investigations, contribute to ETO sterilization processes, and ensure labs are inspection-ready at all times.

Responsibilities:
• Coordinate and execute microbiology activities and investigations related to product sterilization.
• Ensure all work complies with regulatory standards, company policies, and SOP's.
• Lead, develop, and manage a team of quality operators and technicians in the Quality Control Lab.
• Oversee compliance with ETO sterilization, microbiology, and GLP.
• Maintain and improve Cleanroom standards, ensuring compliance at all times.
• Lead root cause investigations for product failures
• Support sterilization-related inquiries.
• Maintain laboratory safety and equipment readiness for internal, customer, or regulatory inspections.
• Manage dose establishment, dose audits, and report preparation for the department.
• Review product lots and approve them for release, ensuring compliance with quality standards.
• Collaborate with technical specialist groups and integrate their insights into quality processes.

Interested applicants should have:

• A degree in Science or a related discipline, with specialisation in Microbiology.
• At least 5 years' experience in the healthcare industry, ideally in pharmaceuticals, biotech, or medical devices.
• Hands-on laboratory experience and a deep understanding of ETO sterilization and microbiology.
• Knowledge of ISO 9001/2000 or ISO 13485 standards and FDA regulations.
• Experience in process validation, cleanroom operations, and CAPA system management.
• Exceptional interpersonal and communication skills, with proven success in a cross-functional team environment.
• Ability to work in a Lean Manufacturing environment, driving continuous improvement.