Senior Microbiology Specialist

5 days ago


Dublin, Dublin City, Ireland beBeeMicrobiologist Full time €60,000 - €80,000
Job Title:
Senior Microbiologist RoleCoordinate 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 failuresSupport 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.

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.

Benefits:

  • Top salary
  • Bonus or Shares
  • Pension
  • Healthcare
  • 24 days Holidays

Company Description:

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

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



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