Senior Computer Systems Validation (CSV) Specialist – Veeva Quality, GAMP 5 & AI Validation

Axiom Path • Bridgewater Township, NJ

6d

About The Position

The Senior Computer Systems Validation (CSV) Specialist provides hands-on validation expertise, strategic guidance, and project oversight for critical GxP-regulated business applications. The role supports enterprise applications, quality management platforms, customized systems, and emerging AI-enabled technologies, ensuring computerized systems remain compliant, reliable, and inspection-ready throughout their lifecycle.

The specialist leads risk-based validation activities, with emphasis on Veeva platforms—including Veeva Quality, Veeva QMS, and Veeva RIMS—and custom-developed GxP systems. The role applies GAMP 5 and Computer Software Assurance principles, prepares and maintains validation documentation, oversees testing and discrepancy resolution, and coordinates deliverables and approvals across multiple projects. It also supports the validated state of regulated systems, maintains controlled records in Veeva, and advises and trains system owners and project stakeholders on validation expectations and documentation.

This is a W2-only engagement, with no C2C or 1099 arrangements. The position is based in Bridgewater, New Jersey; onsite expectations are to be confirmed. The contract is approximately 12 months, with an anticipated start in November 2026.

Requirements

• 5–10+ years of hands-on Computer Systems Validation experience, preferably in pharmaceutical, biotechnology, or another highly regulated life sciences environment.
• Demonstrated experience validating Veeva platforms, particularly Veeva Quality, Veeva QMS, and Veeva RIMS.
• Practical experience validating GAMP Category 5 applications, including customized or bespoke computerized systems.
• Understanding of validation considerations for AI tools and applications, including assessment of GxP relevance and potential compliance risks.
• Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, GCP, and data integrity requirements.
• Familiarity with FDA Computer Software Assurance principles and risk-based validation methodologies.
• Ability to independently author, review, and manage validation plans, requirements specifications, qualification protocols, testing evidence, and summary reports.
• Experience managing validation documentation, review cycles, and approvals within controlled document management systems.
• Ability to oversee multiple validation initiatives, coordinate cross-functional stakeholders, and maintain project deliverables.
• Strong technical writing, analytical thinking, organizational, and problem-solving capabilities.
• Effective communication skills and ability to guide technical teams and nontechnical system owners through validation requirements.
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related discipline.

Responsibilities

• Lead computerized system validation activities across multiple projects, ensuring applications are implemented, maintained, and operated in accordance with quality and regulatory standards.
• Develop and execute risk-based validation strategies for enterprise applications, including Veeva Quality, Veeva QMS, Veeva RIMS, and customized GxP systems.
• Evaluate AI-enabled tools and applications to determine GxP applicability, associated risks, and appropriate validation approaches.
• Prepare and maintain validation plans, user and functional requirements, IQ, OQ, PQ, and validation summary reports.
• Provide technical oversight during test execution, review completed protocols, investigate discrepancies, and ensure validation evidence meets documentation and quality requirements.
• Apply GAMP 5 principles and Computer Software Assurance concepts to develop risk-based testing and validation methodologies.
• Coordinate validation deliverables, approvals, and documentation workflows across multiple simultaneous projects.
• Maintain controlled validation records and supporting documentation within Veeva.
• Support the ongoing validated state of regulated computerized systems through lifecycle management and compliance with internal procedures.
• Train, coach, and advise system owners and project stakeholders on validation expectations, testing practices, and documentation requirements.
• Ensure project participants complete applicable training before performing regulated validation activities.
• Collaborate with IT, Quality, Regulatory, and business stakeholders to resolve validation challenges and maintain project timelines.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior