Computer System Validation (CSV) Engineer

Computer System Validation (CSV) EngineerLocation: Los Angeles Metropolitan AreaLong-Term Project Note: This opportunity is open to W-2 employees only. Corp-to-Corp (C2C) candidates are not eligible.Job SummaryWe are seeking a detail-oriented Computer System Validation (CSV) Engineer / Specialist with hands-on experience in validating computerized systems within regulated environments such as pharmaceutical, life sciences, or medical devices.The ideal candidate will have strong expertise in GAMP 5 guidelines, experience validating ERP systems (e.g., SAP, Oracle ERP, Epicor), and a solid understanding of validation lifecycle processes and regulatory compliance.Key ResponsibilitiesPerform end-to-end Computer System Validation (CSV) activities in compliance with regulatory requirementsDevelop, review, and execute validation documentation, includingValidation Plans (VP)User Requirements Specifications (URS)Functional/Design Specifications (FS/DS)Risk Assessments (RA)IQ/OQ/PQ protocols and reportsRequirements Traceability Matrix (RTM)Apply risk-based validation approach aligned with GAMP 5Execute validation protocols and document test results, deviations, and discrepanciesPerform validation for:ERP systems (inventory, manufacturing, quality modules)Custom-developed applicationsSystem integrations and data integrity workflowsSupport software lifecycle activities including change control, deviation management, and periodic reviewEnsure compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11Collaborate with cross-functional teams including QA, IT, Development, and Business stakeholdersParticipate in audits and inspections; provide documentation and validation support Required QualificationsBachelor’s degree in Engineering, Computer Science, Life Sciences, or related field2–6 years of experience in Computer System Validation (CSV)Strong understanding of GAMP 5 and validation lifecycle (V-model)Hands-on experience validating ERP systems (e.g., SAP, Oracle, Epicor)Experience validating custom software applications and automated systemsKnowledge of:Risk management principlesData integrity requirementsSoftware Development Life Cycle (SDLC)Experience with documentation and tracking tools (e.g., Excel, JIRA, Azure DevOps, ALM tools)Strong analytical, documentation, and communication skills.