Chief Data Validation Specialist

2 weeks ago

Galway, Galway, Ireland beBeeCsvEngineer Full time €90,000 - €120,000
Job Title: Csv Engineer

We are seeking a skilled expert to lead validation and assurance efforts across our clients' critical systems.

As a key advisor to IT, Operations, and QA teams, you will ensure systems meet regulatory and quality standards (21 CFR Part 11, EU MDR, 21 CFR 820).

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

  • 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
  • Utilize tools like Excel and Minitab for data analysis and reporting
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
  • Excellent communication and documentation skills
Bonus Points For:
  • Experience validating manufacturing automation systems (MES, PLC, SCADA)
  • ASQ Software Quality Engineer certification
  • Familiarity with Six Sigma or TQM principles

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