Validation Engineer

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities within a regulated pharmaceutical environment. This role will focus on validating Veeva Quality Vault and ensuring compliance with GxP, FDA, and industry standards.

• Support end-to-end validation of Veeva Quality Vault
  , including new implementations, releases, and enhancements.
• Conduct risk assessments for system upgrades and change controls to determine appropriate validation scope.
• Develop and maintain CSV documentation, including:
• Validation Plans
• URS (User Requirement Specifications)
• Traceability Matrices
• IQ/OQ/PQ Protocols & Test Scripts
• Summary & Final Validation Reports
• Collaborate with system owners, QA, IT, and process owners to define validation requirements.
• Ensure compliance with 21 CFR Part 11
  , GxP guidelines, GAMP 5, and internal quality procedures.
• Support audits, system releases, and change management activities.

• Previous experience as a Quality CSV Engineer/Consultant in a pharmaceutical setting.
• Hands‑on experience validating Veeva Quality Vault (Quality Docs, QMS, Training, etc.).
• Strong understanding of CSV lifecycle, risk-based validation, and regulatory compliance.
• Ability to create high-quality validation documentation (VP, URS, TM, IQ/OQ/PQ).
• Excellent communication skills and experience working cross‑functionally with QA, IT, and business teams.

• Mid‑Senior level

• Contract

• Pharmaceutical Manufacturing and Biotechnology Research

San Francisco, CA $99,500.00-$ 2 days ago