Validation Engineer

United Pharma Technologies Inc; California (MO); On-site; USD 99,500 - 200,000; Full time

Job summary

A pharmaceutical technology company is seeking a skilled Computer System Validation Engineer to support the validation of Veeva Quality Vault and ensure compliance with industry standards. The ideal candidate has experience in a regulated environment and is adept at developing validation documentation. This contract role offers a competitive salary range of $99,500.00 to $200,000.00, located in California.

Qualifications

• Previous experience in a pharmaceutical setting.
• Hands-on experience with Veeva Quality Vault.
• Strong understanding of regulatory compliance.

Responsibilities

• Support end-to-end validation of Veeva Quality Vault.
• Conduct risk assessments for system upgrades.
• Develop and maintain CSV documentation.
• Ensure compliance with regulatory guidelines.

Skills

Quality CSV Engineer/Consultant experience

Validation of Veeva Quality Vault

Understanding of CSV lifecycle

High-quality validation documentation creation

Communication skills

Job description

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.

Key Responsibilities

• 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.

Required Skills & Experience

• 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.

Seniority level

• Mid‑Senior level

Employment type

• Contract

Job function

• Pharmaceutical Manufacturing and Biotechnology Research

San Francisco, CA $99,500.00-$200,000.00 2 days ago