CSV Engineer – Contractor – East Galway
We’re looking for a skilled CSV Engineer or IT/OT Validation Engineer to lead validation and assurance efforts across our clients’ critical systems. You'll act as a key advisor to IT, Operations, and QA teams, ensuring 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.
What You’ll Do:
* 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
What You Bring:
* 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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Very competitive rates on offer
For a confidential discussion and more information on the role, please contactDavin Ferguson.
davin.ferguson@collinsmcnicholas.ie
071 91 40251
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