The CSV Engineer / Specialist will support validation activities for GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. This is a hands-on role focused on executing CSV lifecycle deliverables in close collaboration with Quality, Engineering, IT, and project teams to ensure regulatory compliance and on-time project delivery.Key ResponsibilitiesExecute end-to-end CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipmentPrepare, review, and support approval of validation documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, and Validation ReportsApply risk-based validation approaches for new and existing systems in line with GAMP 5 principlesEnsure CSV activities comply with cGMP, GAMP 5, EU Annex 11, and 21 CFR Part 11 requirementsPartner with project teams to align validation deliverables with project schedules and milestonesParticipate in validation risk assessments to define appropriate testing scope and strategyReview system specifications, design documentation, installation records, and qualification evidenceSupport validation activities across manufacturing, packaging, and laboratory computerized systemsRaise, track, and support closure of validation deviations, discrepancies, and observationsSupport investigations and assess data integrity risks during validation and routine operationsPerform periodic reviews of computerized systems and support identification of compliance gapsContribute to the development, review, and maintenance of CSV and qualification SOPsSupport regulatory inspections and internal audits as requiredCollaborate with local and global CSV teams to ensure consistent validation executionEscalate potential quality or compliance risks to senior CSV or Quality leadershipAdhere to site EHS and safety procedures during commissioning and validation activitiesQualifications & ExperienceBachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline4–7 years’ experience in Computer System Validation within a regulated pharmaceutical or biopharmaceutical environmentStrong understanding of CSV regulations, industry standards, and quality expectationsHands-on experience validating GAMP Category 3, 4, and 5 systemsProven experience executing validation protocols and managing CSV documentationWorking knowledge of EU Annex 11, 21 CFR Part 11, and GAMP guidelinesExperience supporting investigations, root cause analysis, and CAPA activitiesStrong documentation skills with the ability to collaborate effectively across cross-functional teams
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