Data Validation Specialist

5 days ago


Galway, Galway, Ireland beBeeValidation Full time €60,000 - €80,000

Job Title: Data Validation Specialist

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

About the Role:

  • Lead validation and Computer Software Assurance (CSA) for IT and OT systems, ensuring compliance with regulatory standards.
  • Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation) using GAMP/CSA methodology.
  • Provide risk-based validation guidance aligned with industry requirements.
  • Partner cross-functionally with QA, IT, Engineering, and Manufacturing teams.
  • Support system and process improvements that enhance quality, compliance, and efficiency.
  • Utilize tools like Excel and Minitab for data analysis and reporting.

Key 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, including MES, SCADA, ERP, LIMS, Data Historians.
  • Proven experience developing validation plans, protocols, and risk assessments.
  • Excellent communication and documentation skills.


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