CSV EngineerLocation:Cork, IrelandContract duration:12 month contractWe are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.About the RoleWe are seeking a mid-level Computer System Validation (CSV) Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This role is focused on hands-on execution of CSV lifecycle activities, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.ResponsibilitiesExecute CSV lifecycle activities for GMP computerized systems including MES, DCS, SCADA, and automated equipmentPrepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reportsApply risk-based validation approaches for new and existing systemsEnsure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11Support project teams to align validation activities with delivery timelinesParticipate in validation risk assessments and define testing scopeReview system specifications, design documents, and qualification recordsSupport deviation management, discrepancy resolution, and data integrity assessmentsAssist with periodic system reviews, audits, and regulatory inspectionsSupport development and maintenance of CSV and qualification SOPsCollaborate with cross-functional and global CSV teamsEscalate quality or compliance risks where requiredFollow EHS and site safety procedures during validation activitiesQualificationsBachelor's degree in Engineering, Life Sciences, Computer Science, or related discipline4–7 years' experience in Computer System Validation within pharma or biopharmaStrong understanding of CSV regulations and quality expectationsHands-on experience validating GAMP Category 3, 4, and 5 systemsExperience executing validation protocols and managing validation documentationWorking knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelinesExperience supporting investigations, root cause analysis, and CAPAsStrong documentation and cross-functional collaboration skillsRequired SkillsStrong understanding of CSV regulations and quality expectationsHands-on experience validating GAMP Category 3, 4, and 5 systemsExperience executing validation protocols and managing validation documentationWorking knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelinesExperience supporting investigations, root cause analysis, and CAPAsStrong documentation and cross-functional collaboration skillsPreferred SkillsExperience in a GMP environmentFamiliarity with EHS and site safety procedures