Job DescriptionJob Advertisement: CSV Engineer / SpecialistLocation: IrelandContract: 12-month renewable contractOverviewWe are seeking a dedicated and experienced mid-level Computer System Validation (CSV) Engineer to join our team. This role involves supporting GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The successful candidate will focus on the hands-on execution of CSV lifecycle activities, collaborating closely with Quality, Engineering, IT, and project teams to ensure compliance and timely project delivery.Key ResponsibilitiesExecute CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment.Prepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports.Apply risk-based validation approaches for both new and existing systems.Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11 regulations.Support project teams to align validation activities with delivery timelines.Participate in validation risk assessments and define testing scope.Review system specifications, design documents, and qualification records.Support deviation management, discrepancy resolution, and data integrity assessments.Assist with periodic system reviews, audits, and regulatory inspections.Support the development and maintenance of CSV and qualification SOPs.Collaborate with cross-functional and global CSV teams.Escalate quality or compliance risks as required.Adhere to EHS and site safety procedures during validation activities.QualificationsBachelor's degree in Engineering, Life Sciences, Computer Science, or a related discipline.4–7 years of experience in Computer System Validation within the pharmaceutical or biopharmaceutical industry.Strong understanding of CSV regulations and quality expectations.Hands-on experience validating GAMP Category 3, 4, and 5 systems.Proven experience executing validation protocols and managing validation documentation.Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines.Experience supporting investigations, root cause analysis, and CAPAs.Strong documentation skills and the ability to collaborate effectively across functions.If you are a motivated professional with a passion for ensuring compliance and quality in GMP-regulated environments, we encourage you to apply for this exciting opportunity. Join us and contribute to the success of our projects while advancing your career in Computer System Validation.