Commissioning and Qualification Expert

2 days ago


Dublin, Dublin City, Ireland Gertek Project Management Full time

Gertek Project Management is an engineering consultancy company that provides project management, talent solutions and commissioning qualification and validation services.

We work with many of the world's leading life science and technology companies to deliver their most strategic and complex projects. Our team ensures that all activities meet the current requirements and client needs.

  • Responsibilities include Commissioning and Qualification of new aseptic manufacturing equipment
  • Writing and executing qualification documents such as FAT, SAT, IOQ, PQ protocols
  • Providing support for the development of URS and Functional Specification associated with asepctic processing
  • Providing technical assistance during investigations or process/equipment

Candidates must ensure timely completion of schedules and reports. Periodic review plans must be completed according to site and regulatory requirements.

Candidates will collaborate with various departments/teams in the development and execution of validation activities associated with new equipment/product introductions and process improvements.

Candidates will be responsible for managing validation activities in accordance with company and regulatory requirements (Health & Safety, c GMP, construction, environmental etc.).

The ideal candidate will have advanced knowledge of FAT, SAT, IOQ and risk-based verification.

We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.



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