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.