CSV Validation Lead – GxP Systems Strategist

I.T. Solutions, Inc.; Foster City (CA); On-site; USD 170,000 - 250,000; Full time

Job summary

I.T. Solutions, Inc. in Foster City, CA seeks a senior CSV Lead to own risk-based validation strategy for GxP computerized systems supporting a greenfield biopharma facility.

You will serve as validation lead and approver for DeltaV, Client-X MES, and process knowledge management platforms during technical transfer. Responsibilities include defining qualification approaches, governing change control, and ensuring validated state is maintained through implementation and release readiness.

Qualifications

• 15+ years of CSV experience in GMP-regulated biopharma env.
• Proven Validation Lead and approver for full CSV lifecycle.
• Hands-on validation with DeltaV or similar DCS in GMP biologics.

Responsibilities

• Lead design, execution, and approval of validation plans, IQ/OQ/PQ, risk assessments, and traceability matrices.
• Define risk-based validation strategy aligned with GAMP 5 and data integrity.
• Approve release decisions and manage change control to keep validated state.
• Collaborate with QA, Automation, IT/OT, Engineering, and Manufacturing.

Skills

CSV validation leadership

GxP compliance

DeltaV/DCS validation

Cross-functional collaboration

IQ/OQ/PQ documentation

Education

Bachelor's degree in engineering, life sciences, or related field

Tools

Kneat

ValGenesis

GAMP 5 guidance

Change control systems

Job description

I.T. Solutions, Inc. in Foster City, CA seeks a senior CSV Lead to own risk-based validation strategy for GxP computerized systems supporting a greenfield biopharma facility.

You will serve as validation lead and approver for DeltaV, Client-X MES, and process knowledge management platforms during technical transfer. Responsibilities include defining qualification approaches, governing change control, and ensuring validated state is maintained through implementation and release readiness.