Computer System Validation (CSV) Lead

CSV Lead – PCS, MES & PKMLocation: Foster City, CA (Onsite)Contract: Long-term rolling contractJob SummaryWe are seeking an experienced CSV Lead to own the risk-based validation strategy, validation deliverable approval, and release governance for GxP computerized systems supporting a greenfield clinical biologics drug substance facility.The role will serve as the Validation Lead and CSV approver for a new DeltaV Process Control System (PCS), Manufacturing Execution System (MES), and Process Knowledge Management (PKM) platform supporting technical transfer and manufacturing operations.Systems in ScopeDeltaV Process Control System: Process control, batch execution, alarm and event functionality, and manufacturing equipment/utilities.Manufacturing Execution System (MES): Electronic batch records, master batch records, recipe management, exception handling, and review by exception.Process Knowledge Management (PKM): Recipe, process definition, and critical quality parameter management supporting technical transfer.System Interfaces: GMP data flows across process control, manufacturing execution, laboratory, and enterprise systems.Key ResponsibilitiesServe as the designated Validation Lead and CSV approver for validation plans, specifications, risk assessments, traceability matrices, qualification protocols, discrepancies, validation summary reports, and related deliverables.Own and execute the risk-based validation strategy aligned with GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU GMP Annex 11, ALCOA+, and applicable CSV procedures.Define software categorization and configured library reuse strategies for the process control system.Determine, with documented justification, where supplier qualification, integrator FAT/SAT, and prior-deployment evidence can be leveraged within the risk-based testing strategy.Define the qualification approach for DeltaV/PCSD libraries, including standard, unmodified module classes and site-modified or custom library objects.Ensure appropriate design documentation, impact assessments, risk assessments, testing, and version control for modified/custom library components.Participate in requirements, design, configuration, and risk assessment workshops.Govern change control, change impact assessments, and regression testing to maintain the validated state.Define and approve integration qualification strategies across process control, MES, laboratory, and enterprise systems.Coordinate integration testing with equipment availability, CQV activities, and overall project milestones.Required QualificationsBachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.10-15 years of CSV experience within a GMP-regulated biopharmaceutical environment.Demonstrated experience serving as a Validation Lead and approver for GxP computerized systems through the complete validation lifecycle.Experience with greenfield or major capital projects.Hands-on validation experience with DeltaV or comparable distributed control systems in GMP biologics manufacturing.Strong understanding of batch, recipe, phase, and ISA-88 library qualification, including standard versus site-modified libraries.Experience validating MES platforms, including electronic batch records, master batch records, recipe qualification, exception handling, and review by exception.Practical experience applying GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles.Experience applying risk-based testing and supplier leverage strategies.Experience authoring, reviewing, and approving the complete CSV deliverable lifecycle, including:Validation PlansURSFRSDesign/Configuration SpecificationsRisk AssessmentsTraceability MatricesIQ/OQ/PQ ProtocolsDiscrepancies/DeviationsValidation Summary ReportsExperience with electronic validation/document management platforms such as Kneat, ValGenesis, or equivalent.Experience with GMP change control systems.Strong written and verbal communication skills with the ability to drive cross-functional decisions.