We are working with a leading life sciences organisation in Ireland who are seeking a CSV Engineer to join on a 12-month fixed-term contract.This role will focus on ensuring computerised systems are validated, compliant, and maintained in a validated state across a regulated manufacturing environment.What you’ll be doing:Leading and supporting Computer System Validation (CSV) activitiesWriting and executing validation documentation (URS, FS, DS, IQ/OQ/PQ)Ensuring compliance with GAMP 5 and data integrity (ALCOA+) standardsSupporting system implementations, upgrades, and changesWorking closely with IT, QA, Automation, and Manufacturing teamsSupporting audit and inspection readinessDay-to-day looks like:Developing and reviewing validation documentationCoordinating testing and system validation activitiesSupporting MES, LIMS, ERP, or automation system updatesEnsuring systems remain in a validated stateWorking cross-functionally with technical and QA teamsWhat we’re looking for:Experience in CSV within Pharma, Biotech, or Medical DevicesStrong knowledge of GAMP 5 and data integrity principlesExperience with systems such as MES, LIMS, ERP, or SCADAStrong documentation and stakeholder management skills
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