Validation Lead

CSV Lead – SCADA, Historian and Scientific Data Platform

Location: Foster City, CA (Onsite 5 days a week)

Long Term Rolling Contract 

Job Summary:

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 controlled changes to the Ignition SCADA and AVEVA Historian platforms in support of equipment and system-to-system integration, and for the GxP deployment and qualification of the TetraScience scientific data platform.

Systems in Scope

• Ignition SCADA: Controlled changes supporting environmental and utility monitoring, remote alarming, and new equipment integration.
• AVEVA Historian: Controlled changes supporting GMP data collection, contextualization, and trending.
• TetraScience: GxP deployment and qualification of laboratory and at-line instrument data integration.
• Interfaces: Validation of data flows between SCADA, historian, process control, and manufacturing execution systems.

Key Responsibilities

• 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 client’s CSV procedures.
• Determine, with documented justification, where supplier qualification, integrator FAT/SAT, and prior-deployment evidence may be leveraged within the risk-based testing strategy.
• 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 the data integrity/ALCOA+ assessment and approve the qualification approach for cloud-hosted and vendor-managed components, including where client-witnessed or client’s-executed testing is required.
• Make and document release-readiness decisions, and coordinate with the CQV workstream so CSV and equipment qualification activities are sequenced correctly.
• Maintain alignment to the integrated project schedule, escalate validation risks and schedule impacts, and sustain validation ownership after go-live through periodic review and change control.
• Partner with Quality Assurance, Automation, Engineering, IT/OT Infrastructure, Manufacturing, System Owners, and service providers to resolve validation issues and finalize deliverables.