Validation Specialist

2 days ago


Dublin, Dublin City, Ireland Gertek Project Management Full time

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

We partner with many of the world's largest life science & technology companies who entrust us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs.

  • Commissioning and Qualification of new aseptic manufacturing equipment
  • Writing and execution of qualification documentations such as FAT, SAT, IOQ, PQ protocols
  • Provide Support for the development of URS and Functional Specification associated with asepctic processing
  • Provide technical assistance during investigations or process/equipment

Candidates will ensure on-time execution of the schedule and reports. They will also ensure Periodic Review plans are completed per site & regulatory requirements. Collaboration with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements is required.

Candidates will be responsible for managing validation activities in conjunction with all company and regulatory requirements (Health & Safety, c GMP, construction, environmental etc.). Change control assessments which could impact the validated state of process equipment must be provided. Leading Risk assessments, root cause analysis and investigations as applicable is also expected.

The ideal candidate will have previous experience in execution of asepctic equipment/qualification/aseptic processing. Advanced knowledge of FAT, SAT, IOQ and risk-based verification is essential. Previous experience on Kneat/online validation package is highly desirable.

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



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