CSV Engineer – Contractor – East GalwayWe’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 systemsDevelop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation)Provide risk-based validation guidance aligned with GxP, FDA, and EU MDR requirementsPartner cross-functionally with QA, IT, Engineering, and ManufacturingSupport system and process improvements that enhance quality, compliance, and efficiencyUtilize tools like Excel and Minitab for data analysis and reportingWhat 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 methodologyStrong understanding of IT/OT systems (e.g., MES, SCADA, ERP, LIMS, Data Historians)Proven experience developing validation plans, protocols, and risk assessmentsExcellent communication and documentation skillsBonus Points For:Experience validating manufacturing automation systems (MES, PLC, SCADA)ASQ Software Quality Engineer certificationFamiliarity with Six Sigma or TQM principles*******************************************************************************Very competitive rates on offerFor a confidential discussion and more information on the role, please contactDavin Ferguson.davin.ferguson@collinsmcnicholas.ie071 91 40251
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