CSV Lead

The CSV Lead owns the risk-based validation strategy, deliverable approval, and release governance for the GxP computerized systems supporting a greenfield clinical biologics drug substance facility in Foster City. The role serves as the Validation Lead and validation approver for a new DeltaV process control system, a new PAS-X manufacturing execution system, and a process knowledge management platform supporting technical transfer.

• DeltaV Process Control System:
  Process control, batch execution, and alarm and event functionality for manufacturing equipment and associated utilities.
• PAS-X Manufacturing Execution System:
  Electronic batch records, master batch record and recipe management, exception handling, and review by exception.
• Process Knowledge Management:
  Recipe, process definition, and critical quality parameter management in support of technical transfer.
• Interfaces:
  Validation of GMP data flows between process control, manufacturing execution, laboratory, and enterprise systems.

• Serve as the designated Validation Lead and CSV approver for all validation deliverables, including validation plans, specifications, risk assessments, traceability matrices, qualification protocols, discrepancies, and validation summary reports.
• Own the risk-based validation strategy in alignment with GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+ expectations, and CSV procedures.
• Own software categorization and configured library reuse decisions for the process control system, and determine with documented justification where supplier qualification, integrator FAT/SAT, and prior-deployment evidence may be leveraged within the risk-based testing strategy.
• Define the qualification approach for the DeltaV PCSD library, leveraging Emerson-provided standard library documentation and testing evidence for unmodified module classes, and requiring documented design, impact assessment, and risk-based testing for modified or custom library objects, with library version control maintained under change control.
• Participate in requirements, design, and risk assessment workshops, and govern change control and change impact/regression assessments so the validated state is maintained throughout implementation.
• Define and approve the integration qualification approach for data flows across process control, manufacturing execution, laboratory, and enterprise systems, and sequence integration testing against equipment availability and project milestones.
• Make and document release-readiness decisions, ensuring qualification evidence, open discrepancies, periodic review status, and training status support GMP use.
• Maintain alignment to the integrated project schedule, coordinate with the CQV workstream so CSV and equipment qualification activities are sequenced correctly, and elevate validation risks and schedule impacts to project leadership.
• Partner with Quality Assurance, Automation, Engineering, IT/OT Infrastructure, Manufacturing, System Owners, and service providers to resolve validation issues, and sustain validation ownership after go-live through periodic review and change control.

• Bachelor's degree in engineering, Computer Science, Life Sciences, or a related technical discipline, with 15+ years of CSV experience in a GMP-regulated biopharmaceutical environment.
• Demonstrated experience as a Validation Lead and approver for GxP computerized systems through a full validation lifecycle, including greenfield or major capital projects.
• Hands‑on validation experience with DeltaV or comparable distributed control systems in GMP biologics manufacturing, including batch, recipe, phase, and ISA‑88 library qualification, and…