System Validation Expert Wanted

3 days ago


Galway, Galway, Ireland beBeeValidation Full time €45,000 - €55,000
System Validation Specialist

We are seeking a skilled System Validation Specialist to lead validation efforts across our clients' critical systems. You will act as a key advisor to IT, Operations, and QA teams, ensuring systems meet regulatory and quality standards.

Key Responsibilities:
  • Lead validation and Computer Software Assurance (CSA) for IT and OT systems
  • Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation)
  • Provide risk-based validation guidance aligned with GxP, FDA, and EU MDR requirements
  • Partner cross-functionally with QA, IT, Engineering, and Manufacturing
  • Support system and process improvements that enhance quality, compliance, and efficiency
Requirements:
  • 5+ years of experience in computer system validation or software assurance in a regulated environment
  • Deep knowledge of 21 CFR Part 11, 21 CFR 820, ISO 13485, and GAMP/CSA methodology
  • Strong understanding of IT/OT systems (e.g., MES, SCADA, ERP, LIMS, Data Historians)
  • Proven experience developing validation plans, protocols, and risk assessments
  • Excellent communication and documentation skills
Bonus Points:
  • Experience validating manufacturing automation systems (MES, PLC, SCADA)
  • ASQ Software Quality Engineer certification
  • Familiarity with Six Sigma or TQM principles
What We Offer:

Very competitive rates

For a confidential discussion and more information on the role, please contact Davin Ferguson



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