5-10+ years of hands-on Computer Systems Validation (CSV) experience in regulated environments.
Experience validating Veeva platforms, especially Veeva Quality, QMS, and RIMS.
Practical knowledge of GAMP Category 5 applications and bespoke systems.
Understanding of validation for AI tools and compliance risks.
Strong grasp of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements.
Familiarity with FDA Computer Software Assurance (CSA) principles.
Proven ability to manage validation documentation and review cycles.
Responsibilities
Lead validation activities for multiple projects ensuring compliance with quality standards.
Develop risk-based validation strategies for enterprise applications.
Evaluate AI tools for GxP applicability and validation approaches.
Prepare and maintain comprehensive validation documentation.
Provide technical oversight during test execution and review protocols.
Apply GAMP 5 and CSA principles to validation methodologies.
Coordinate validation deliverables and documentation workflows across projects.
Benefits
Engagement as W2 only (no C2C/1099).
Onsite work location in Bridgewater, New Jersey.
Contract duration of approximately 12 months, starting November 2026.
Opportunity to work with enterprise GxP applications in the pharmaceutical sector.
Involvement in validation strategies for emerging AI technologies.
Full Job Description
Job Description Be Part Of A High-Performing Team
This opportunity supports a specialized IT and validation function responsible for ensuring that GxP-regulated computerized systems remain compliant, reliable, and inspection-ready throughout their lifecycle. The team supports enterprise applications, quality management platforms, and emerging technologies, including artificial intelligence, while maintaining alignment with global regulatory expectations.
The Senior Computer Systems Validation (CSV) Specialist will provide hands-on validation expertise, strategic guidance, and project oversight across critical business applications, with particular emphasis on Veeva platforms, custom-developed systems, and risk-based validation practices.
What's In Store For You
Engagement: W2 only (no C2C/1099).
Location: Bridgewater, New Jersey. Onsite expectations to be confirmed.
Contract Duration: Approximately 12 months, with an anticipated start in November 2026.
Work with enterprise GxP applications supporting pharmaceutical quality, regulatory, and business operations.
Contribute to validation strategies for emerging AI-enabled technologies and customized applications.
Collaborate with system owners, IT stakeholders, and quality professionals on multiple computerized system validation initiatives.
Serve as a subject matter expert, providing technical guidance, training, and mentorship to GxP system owners.
How You Will Make An Impact
Lead computerized system validation activities across multiple projects, ensuring applications are implemented, maintained, and operated in accordance with established 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 documentation, including validation plans, user and functional requirements, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation summary reports.
Provide technical oversight throughout test execution, review completed protocols, investigate discrepancies, and ensure validation evidence meets documentation and quality requirements.
Apply GAMP 5 principles and Computer Software Assurance (CSA) concepts to develop effective, 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.
Requirements Do You Bring Proven Success in Computer Systems Validation and GxP-Regulated Applications?
5-10+ years of hands-on Computer Systems Validation (CSV) experience, preferably within pharmaceutical, biotechnology, or another highly regulated life sciences environment.
