Lead Computer System Validation Engineer with GAMP experience required for permanent role with growing healthcare company in Dublin. The successful candidate will play an instrumental role in the development of the company’s Quality Assurance computer system validation strategy, ensuring the processes conform to policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations.


  • Quality review and approval of Validation documentation and SOPs
  • Provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement
  • Develop and maintain qualification plans and test plans, aligned with the overall project plan
  • Ensure consistent implementation of the validation strategy aligned with Secure Software Development LifeCycle (SSDLC) deliverables
  • Approver of all CSV deliverables, ensuring compliance with relevant standards & regulations
  • Provide input to the development of realistic project schedules and document trackers
  • Maintenance of all aspects of GxP compliance
  • Provide guidance, review and approval for all computer-related validation documentation


  • B.Sc. in Chemistry, Biology, Microbiology, Automation, Engineering
  • At least 5+ years’ experience in a similar role delivering validated IT solutions, in a regulated environment
  • Experience working in a GxP environment
  • Expert knowledge of GAMP5
  • GxP computer validation
  • CFR 21 Part 11
  • CFR 21 Part 58
  • IQ, OQ, PQ
  • Related documentation such as assessments, plans, URS, FRS and summary reports


  • ISO 13485
  • CFR 21 Part 82
  • Experience with AGILE and SCRUM

Please contact Emer Smith to discuss in confidence



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