CSV Consultant (Computer System Validation)
Job Title: CSV Consultant (Computer Systems Validation)Location: Redwood City, CAType: ContractJob SummaryWe are seeking an experienced CSV Consultant to support validation activities across multiple GxP-regulated systems within a pharmaceutical environment. This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems.The ideal candidate will have strong experience with validated systems, change control processes, and regulatory compliance in GMP/GxP environments.Key ResponsibilitiesLead and support validation activities for GxP-regulated systems including:SAS StudioVeeva Quality DocsCTMSTraceLinkArgusSupport system revalidation and data migration projects to ensure compliance and data integrityDevelop, review, and execute validation documentation including:Validation PlansUser Requirements Specifications (URS)Risk AssessmentsIQ/OQ/PQ protocolsTraceability MatricesSummary ReportsCreate and support User Acceptance Testing (UAT) scripts and execution activitiesManage change control documentation and support deviation resolution activitiesEnsure validation activities align with FDA, GAMP5, and GxP compliance requirementsCollaborate with IT, Quality, Clinical, and Business stakeholders to support validated system implementations and updatesMaintain accurate and compliant documentation throughout the system lifecycleRequired QualificationsBachelor s degree in Computer Science, Engineering, Life Sciences, or related field5+ years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environmentsHands-on experience validating GxP systems and supporting regulated system implementationsStrong knowledge of FDA 21 CFR Part 11, GAMP5, and GxP requirementsExperience with validation documentation, UAT execution, and change control processesFamiliarity with systems such as SAS Studio, Veeva, CTMS, TraceLink, or ArgusStrong analytical, documentation, and communication skills