SummaryA CSV Engineer is required to support a biopharmaceutical manufacturing environment in West Dublin. The successful candidate will be responsible for delivering CSV activities across technical projects, ensuring compliance with cGMP, data integrity, and regulatory requirements. The ideal candidate will provide independent quality oversight of system lifecycle documentation for GxP systems, including automated equipment, DCS, MES, and associated infrastructure, while working closely with Engineering, Automation, Quality, and Operations teams to support project delivery and site operations.ResponsibilitiesAct as a Computer System Validation Subject Matter Expert (SME) for systems supporting GMP manufacturing, including MES, DCS, and automated equipmentPrepare, review, and approve CSV lifecycle documentation, including validation plans, user requirements, risk assessments, protocols, reports, and summary documentationSupport the development and execution of CSV strategies for new and existing computerised systems, applying risk-based and leveraged validation approachesEnsure CSV activities comply with applicable regulations and guidelines, including cGMP, GAMP 5, Annex 11, and 21 CFR Part 11Provide proactive CSV support to project teams to ensure validation activities align with project timelinesParticipate in validation risk assessments to define appropriate levels of testing for new or modified systemsReview equipment specifications, design documentation, installation records, and qualification documentationSupport validation activities across manufacturing, packaging, and laboratory areasGenerate, manage, and resolve validation deviations, discrepancies, and documentation issuesSupport investigations and assess potential data integrity risks arising during validation or routine operationsPerform periodic reviews of computerised systems and identify any compliance gapsContribute to the development and maintenance of Qualification and Validation SOPsSupport regulatory inspections and internal audits related to computerised systemsWork closely with local and global CSV teams to ensure consistency and alignment across projectsEscalate potential compliance or quality risks in a timely and appropriate mannerPromote safe working practices and adherence to site EHS requirementsSupport commissioning and validation activities in compliance with site safety proceduresQualifications & ExperienceDegree in Engineering, Life Sciences, Computer Science, or a related technical discipline preferredMinimum 5 to 7 years’ experience in Computer System Validation or a related technical role within a regulated biopharmaceutical or life sciences environmentStrong understanding of current quality and regulatory requirements for computerised systemsHands-on experience validating GAMP Category 3, 4, and 5 systemsProven experience executing validation protocols, managing validation data, and ensuring data integrityIn-depth knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelinesExperience supporting investigations, root cause analysis, and corrective actions related to validation or data integrity issues
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