CSV Engineer (Computer System Validation Engineer)Duration:12 MonthsLocation:Cruiserath, DublinWorking hours:39 hours per weekOnsite requirements:OnsiteEngagement Type:Via LTD CompanyDay Rate:€478.26 per dayLegal Right to Work:Applicants must have the legal right to work in the relevant location. No sponsorship is available for this position.Atrium Global is supporting a client within the life sciences industry to secure an experienced CSV Engineer for a long-term assignment.Job OverviewThe role focuses on delivering compliant validation activities across computerised systems within a regulated environment. The successful candidate will support validation planning, execution, documentation and ongoing compliance, collaborating with cross-functional teams to ensure systems meet regulatory and industry standards.RESPONSIBILITIESDevelop and execute validation protocols including IQ, OQ and PQCreate validation plans, test scripts, RTMs and summary reportsPerform risk assessments and impact analysesConduct periodic reviews to ensure ongoing complianceSupport change control activities and assess validation impactCollaborate with IT, QA, Operations and other key stakeholdersProvide CSV guidance and best practice support across projectsKeep up to date with regulatory developments and industry trendsWork with vendors to ensure validated deliverablesSupport audit preparation and participate in inspectionsQualify laboratory analytical instrumentsQualify manufacturing automation systems such as DeltaV and MESREQUIREMENTSDegree in Computer Science, Engineering or related disciplineStrong knowledge of FDA 21 CFR Part 11, EU Annex 11 and GAMP 5Experience in CSV within a regulated pharma or biotech environmentCompetence with risk-based validation approachesSkilled in developing and executing validation documentationStrong analytical and problem-solving ability with attention to detailEffective communication and collaboration skillsAbility to manage multiple projects independentlyUnderstanding of SDLC and change control processesKnowledge of data integrity requirements and application