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Senior Validation Specialist

3 weeks ago


Galway, Galway, Ireland beBee Careers Full time
Validation Engineer Job Opportunity

About this role:

  • Lead and execute validation protocols (IQ, OQ, PQ) for facility systems and equipment.
  • Develop and manage validation plans, summary reports, and change control documentation in line with site and regulatory standards.

Key Responsibilities:

  1. Support commissioning and qualification activities for HVAC, cleanrooms, utilities (WFI, compressed air, etc.), and facility upgrades.
  2. Ensure compliance with FDA, ISO 13485, EU GMP, and company quality standards.
  3. Coordinate with engineering, quality, and project teams to ensure timely delivery of validation deliverables.

Required Qualifications:

  • Degree in Engineering, Science, or related discipline.
  • Experience in a GMP-regulated environment, preferably in medical devices or pharmaceuticals.

Desirable Skills:

  • Strong understanding of validation lifecycle and quality systems.
  • Experience working onsite in facility or capital project environments at a pharma/biomedical site preferred.