Job DescriptionBe Part Of A High-Performing TeamThis 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.
RequirementsDo 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.
- 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 (CSA) principles and risk-based validation methodologies.
- Demonstrated 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 with the 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.
