Systems Assurance Specialist

2 weeks ago


Galway, Galway, Ireland beBeeValidation Full time €60,000 - €90,000
Validation and Assurance Expert

We are seeking a skilled Validation and Assurance professional to lead validation efforts across our clients' critical systems.

This is a dynamic, hands-on role supporting both enterprise IT and operational technology environments.

  1. Lead validation and Computer Software Assurance (CSA) for IT and OT systems
  2. Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation)
  3. Provide risk-based validation guidance aligned with GxP, FDA, and EU MDR requirements
  4. Partner cross-functionally with QA, IT, Engineering, and Manufacturing
  5. 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 (medical device/pharma)
  • 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

Bonus Points For:

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

What We Offer:

  • Competitive rates
  • A confidential discussion and more information on the role, please contact us.


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