Data Integrity Specialist

2 weeks ago


Galway, Galway, Ireland beBeevalidation Full time €80,000 - €100,000
Validation Expert Wanted

We are seeking a skilled professional to lead validation and assurance efforts across critical systems.

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
Required Qualifications:
  • 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
Preferred Skills:
  • Experience validating manufacturing automation systems (MES, PLC, SCADA)
  • ASQ Software Quality Engineer certification
  • Familiarity with Six Sigma or TQM principles

This is a dynamic, hands-on role supporting both enterprise IT and operational technology environments. The ideal candidate will possess strong technical skills, excellent communication skills, and the ability to work effectively in a team environment.



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