Validation and Commissioning Specialist

3 days ago


The Municipal District of Carlow, Ireland Headcount Solutions Full time

We are looking for a skilled Validation and Commissioning Specialist to join our team at Headcount Solutions. The ideal candidate will have a strong background in validation and commissioning, with experience working on large-scale projects in the biopharma industry.

About the Role
  • This role will involve managing a team of validation engineers and coordinating with cross-functional teams to ensure successful project delivery.
  • You will be responsible for developing and implementing validation strategies, as well as ensuring compliance with regulatory requirements.
  • The successful candidate will have excellent communication and problem-solving skills, with the ability to work effectively in a fast-paced environment.

To succeed in this role, you will need:

  • A minimum of 6 years' experience in C&Q/QA/QC/Validation in a highly regulated industry.
  • Strong knowledge of ASTM E2500/Eudralex/FDA/ISPE guidelines.
  • Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS, and QA.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.


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