Senior Microbiologist Specialist

5 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

Job Overview:

We are seeking a highly skilled Senior Microbiologist to join our team in Dun Laoghaire, Dublin. As a key member of our Quality Control Laboratory, you will play a pivotal role in ensuring that our products meet the highest regulatory and company standards.

About Us:

Our client has been accelerating the journey to better diabetes care for nearly 100 years. With the creation of the first insulin delivery device, they have delivered an innovation that moved the management and treatment of diabetes forward.

Key Responsibilities:

  • 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.
  • Perform other relevant duties as assigned by management.

Requirements:

  • 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.


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