Senior Microbiologist Role
We are seeking an experienced Senior Microbiologist to join our team in Dun Laoghaire, Dublin. The ideal candidate will have a strong background in microbiology and experience in ensuring product quality and compliance with regulatory standards.
About the Role
This is an exciting opportunity to work in a dynamic environment where you will be responsible for coordinating microbiology activities, executing investigations, and leading a team of quality operators and technicians. You will also be responsible for ensuring compliance with ETO sterilization, microbiology, and GLP standards.
The successful candidate will have a degree in Science or a related discipline, with specialization in Microbiology, and at least 4 years of experience in the healthcare industry, specifically in pharmaceuticals, biotech, or medical devices.
* Coordinate and execute microbiology activities and investigations related to product sterilization.
* Ensure all work complies with regulatory standards, company policies, and SOPs.
* 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.
Key Qualifications
* A degree in Science or a related discipline, with specialization in Microbiology.
* 4+ years of experience in the healthcare industry, specifically 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.
What We Offer
We offer a top salary, bonus or shares, pension, healthcare, and 24 days holidays. This is a fantastic opportunity to work with a leading organization in the field of diabetes care.