Senior CSV Lead for GMP Validation (DeltaV & PAS-X)

Valspec; San Francisco (CA); Vor Ort; USD 180.000 - 280.000; Vollzeit

Zusammenfassung

Valspec in Foster City is seeking a CSV Lead to own risk-based validation strategy, deliverable approval, and release governance for GxP computerized systems supporting a greenfield biologics facility.

You will serve as Validation Lead and approver for DeltaV process control, PAS-X MES, and process knowledge management, coordinating with QA, IT/OT, engineering, and manufacturing to ensure GMP compliance.

Qualifikationen

• Bachelor's degree in engineering or life sciences.
• 15+ years' CSV experience in GMP biopharma.
• Leadership as validation lead and approver.
• Experience with DeltaV and PAS-X in GMP manufacturing.

Aufgaben

• Lead CSV strategy, plans, and risk assessments.
• Approve validation deliverables and change control.
• Govern data flows across PCS, MES, LIMS, and ERP.
• Coordinate with QA, IT/OT, engineering, and manufacturing.

Kenntnisse

CSV leadership

GxP validation

Risk-based testing

Change control

GAMP 5

Ausbildung

Bachelor's degree in engineering/life sciences

Tools

DeltaV

PAS-X

Kneat

ValGenesis

Jobbeschreibung

Valspec in Foster City is seeking a CSV Lead to own risk-based validation strategy, deliverable approval, and release governance for GxP computerized systems supporting a greenfield biologics facility.

You will serve as Validation Lead and approver for DeltaV process control, PAS-X MES, and process knowledge management, coordinating with QA, IT/OT, engineering, and manufacturing to ensure GMP compliance.