Computer System Validation Specialist

Job SummaryThe Computer System Validation (CSV) Quality Specialist is responsible for ensuring computerized systems used in regulated manufacturing environments meet compliance, validation, and data integrity requirements. This role serves as the Quality reviewer and approver for manufacturing and digital platforms, applying risk-based validation principles to support efficient project execution while maintaining regulatory inspection readiness.ResponsibilitiesReview and approve CSV lifecycle documentation including VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, and Summary Reports.Ensure validation strategies align with GAMP 5, 21 CFR Part 11, and ALCOA+ data integrity principles.Assess system changes through change control processes, determining GxP impact and validation requirements.Support periodic reviews and re-validation of existing computerized systems.Act as Quality reviewer/approver for manufacturing and laboratory systems such as:MES/EBR platforms (e.g., Werum PAS-X or similar)Data historians (e.g., OSIsoft PI or equivalent)Advanced analytics tools (e.g., Seeq)Empower and other laboratory systemsReview system configurations related to data acquisition, time stamping, audit trails, access controls, and electronic records/signatures.Ensure appropriate segregation between GxP and non-GxP system usage.Evaluate and approve system data flows, interfaces, and integrations.Support regulatory inspections (e.g., FDA, EMA) and internal audits related to computerized systems validation and compliance.QualificationsMaster's degree in Engineering, Computer Science, Life Sciences, or related field (recent graduates encouraged).3–5 years of experience in pharmaceutical or regulated manufacturing, including at least 2 years within a Quality organization.Minimum 3 years of hands-on CSV experience reviewing and approving validation documentation.Direct experience supporting manufacturing or utilities systems (not limited to laboratory systems).Strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity (ALCOA+) principles.