Senior CSV Validation Lead – GMP SCADA & Data Platform

I.T. Solutions, Inc.; Foster City (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

I.T. Solutions, Inc. in Foster City, CA is seeking a CSV Lead to own risk-based validation for Ignition SCADA, AVEVA Historian, and TetraScience platforms in a GMP biopharma setting.

This onsite, long-term contract role focuses on validation governance, data integrity, and supplier leverage for complex integration projects. The candidate will lead validation deliverables, coordinate change control, and ensure compliance with 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles throughout

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or related technical discipline; 15+ years CSV experience in GMP biopharmaceuticals.
• Experience as Validation Lead and CSV approver for GxP systems across full lifecycle.
• Knowledge of GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, ALCOA+.

Responsibilities

• Lead validation deliverables: plans, URS/FRS, IQ/OQ/PQ, risk assessments, traceability matrices, discrepancies, summaries.
• Define risk-based validation strategy aligned with GMP standards and client CSV procedures.
• Coordinate with QA, IT/OT, Engineering, and Manufacturing to resolve validation issues and maintain validated state.

Job description

I.T. Solutions, Inc. in Foster City, CA is seeking a CSV Lead to own risk-based validation for Ignition SCADA, AVEVA Historian, and TetraScience platforms in a GMP biopharma setting.

This onsite, long-term contract role focuses on validation governance, data integrity, and supplier leverage for complex integration projects. The candidate will lead validation deliverables, coordinate change control, and ensure compliance with 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles throughout