Validation Engineer – Galway

A Medical Device multinational based in Galway are seeking a Validation Engineer with experience working within a highly regulated environment specifically Medical Devices to join their expanding team.

Responsibilities:

  • Generate validation documentation and assist in the execution of protocols.
  • Troubleshoot validation issues associated with the validation project and provide feedback.
  • Ensure consistency on validation/qualification approach across systems and projects.
  • Ensure validation documents are up-to-date.
  • Manage the execution of the product/process validation as per the MVP and project plan.
  • Work directly with customer validation representatives to define inputs and requirements.
  • Ensure all results and data are correct and follow-up on any gaps.
  • Liaise with the Engineering function to ensure that equipment validation requirements are maintained.
  • Provide guidance and direction in the preparation and execution of validation activities.
  • Maintain validation procedures and templates up to date, focusing on continuous improvement.

Requirements:

  • BSc. in Science/Engineering.
  • 3+ years’ experience in a similar role within the Medical Devices.
  • Strong knowledge of ISO and FDA quality requirements.
  • Good understanding of validation concepts and documentation.
  • Excellent attention to detail and report-writing ability.
  • Strong ability to prioritize tasks.
  • General knowledge of statistical analysis methods advantageous.
  • Some travel may be required.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

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