Cleanroom Validation Manager

6 days ago


Sligo, Sligo, Ireland beBee Careers Full time
Lead Microbiologist

We are looking for a highly motivated and experienced microbiologist to join our team as a cleanroom validation manager.

The successful candidate will have a strong background in microbiology and experience in working with biopharmaceutical products.

Key responsibilities include:

  • Managing and coordinating site environmental monitoring programs.
  • Developing and implementing a detailed action plan, including timelines, resource allocation, cost, and risk management strategies.
  • Ensuring all microbiological practices comply with GMP and regulatory requirements.
  • Conducting regular audits and inspections to maintain a high standard of cleanliness, sterility, and bioburden control.

Requirements include:

  • Bachelor's degree in Microbiology, Biotechnology, or equivalent. Master's degree is desirable.
  • Minimum of 5 years' experience in a similar role, ideally in a biopharmaceutical manufacturing facility (experience in a facility with Grade A cleanrooms and aseptic processing is highly desirable).
  • Extensive experience with cleanroom validation and qualification processes.
  • Experience managing and coordinating site environmental monitoring programs.

(Core Competencies)

  • In-depth knowledge of GMP regulations and guidelines.
  • Specific knowledge of aseptic process simulations, cleanroom qualifications, and deep understanding of Annex 1 guidance.
  • Expertise in microbiological testing, environmental monitoring, and contamination control.
  • Excellent project management and organizational skills.


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