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

Be Part Of A High-Performing Team

Join an innovative biopharmaceutical organization dedicated to developing transformative therapies for patients with serious and rare diseases. Operating in a highly regulated environment, the company emphasizes scientific innovation, quality, regulatory compliance, and the integrity of its technology systems.

The Computer Systems Validation (CSV) team plays a critical role in supporting the implementation, enhancement, and ongoing compliance of GxP-regulated computerized systems across the organization. This specialized team oversees validation activities for cloud-based and on-premises applications, collaborating with IT, Quality Assurance, business stakeholders, and external partners to ensure systems meet regulatory expectations.

With a growing portfolio of technology initiatives, the team is seeking an experienced Senior CSV Lead who can independently manage multiple validation projects, develop risk-based validation strategies, and provide technical leadership throughout the computerized system lifecycle.

What's In Store For You

• Engagement: W2 only (no C2C/1099).
• Location: Hybrid – Bridgewater, NJ. Predominantly remote, with flexible onsite attendance based on project requirements, including occasional multiple-day onsite support for testing activities.
• Contract Duration: Approximately 12 months.
• Opportunity to lead CSV activities across multiple enterprise technology initiatives, including Veeva applications and customized GxP systems.
• Work with a specialized team that values independent decision-making, technical expertise, and practical risk-based validation approaches.
• Gain exposure to emerging technologies, including AI-enabled applications and evolving Computer Software Assurance methodologies.
• Collaborate with cross-functional stakeholders while providing validation guidance and supporting continuous improvements in regulated system practices.

How You Will Make An Impact

• Lead computerized system validation activities across multiple projects, including new system implementations, upgrades, and enhancements to existing GxP applications.
• Develop and implement project-specific, risk-based CSV strategies aligned with regulatory requirements, GAMP 5 principles, and Computer Software Assurance (CSA) concepts.
• Evaluate system functionality, intended use, and GxP impact to determine appropriate validation deliverables, documentation requirements, and testing approaches.
• Serve as the CSV Lead for enterprise applications, including Veeva Quality, Veeva QMS, Veeva Medical, Veeva Training, and other regulated computerized systems.
• Independently author validation plans and validation summary reports, ensuring validation strategies, execution results, and conclusions are clearly documented.
• Review, co-author, and provide technical guidance on requirements specifications, functional specifications, IQ/OQ/PQ protocols, test scripts, and other validation lifecycle documentation.
• Oversee documentation prepared by business system owners, IT personnel, Quality Assurance teams, vendors, and external service providers to ensure compliance with established validation standards.
• Coordinate project meetings, track validation milestones, manage deliverable timelines, and proactively address risks or issues affecting project execution.
• Provide oversight during test execution, review completed protocols and supporting evidence, and help resolve discrepancies or documentation gaps.
• Support validation document approval processes, training compliance, and maintenance of controlled records within Veeva and applicable quality management systems.
• Collaborate with technical and business stakeholders to maintain computerized systems in a validated state throughout their operational lifecycle.
• Provide guidance and mentorship to system owners and project participants regarding validation requirements, testing expectations, and documentation practices.
• Contribute to the evaluation of emerging technologies, including AI-enabled applications, by assessing GxP relevance, intended use, system reliability, and appropriate validation strategies.
• Independently manage competing project priorities while maintaining effective communication with project stakeholders and leadership.

Requirements

Do You Bring Proven Success in Leading Computer Systems Validation and Risk-Based GxP Compliance?

• 5–10 years of hands-on Computer Systems Validation (CSV) experience, preferably within pharmaceutical, biotechnology, or other GxP-regulated life sciences environments.
• Demonstrated experience leading CSV activities for computerized system implementations, enhancements, upgrades, or lifecycle management initiatives.
• Hands-on Veeva validation experience involving one or more Veeva applications, such as Veeva Quality, Veeva QMS, Veeva Medical, Veeva Training, or Veeva RIMS.
• Strong understanding of risk-based validation methodologies, with the ability to assess system risks and determine appropriate validation documentation and testing requirements.
• Proven experience independently authoring validation plans and validation summary reports, along with previous hands-on experience developing requirements, specifications, qualification protocols, and supporting CSV deliverables.
• Experience reviewing, co-authoring, and overseeing validation documentation prepared by cross-functional stakeholders or external vendors.
• Experience validating GAMP Category 5 custom-built or bespoke computerized systems.
• Solid 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) concepts and their application to risk-based testing and validation strategies.
• Ability to independently manage multiple validation projects, coordinate competing priorities, and provide technical direction without constant supervision.
• Strong technical writing, analytical thinking, critical decision-making, and problem-solving skills.
• Excellent communication and stakeholder management abilities, including experience collaborating with IT, Quality Assurance, business system owners, and third-party service providers.
• Experience supporting validation testing activities, reviewing executed protocols, and maintaining compliant validation documentation.
• Ability to evaluate validation approaches pragmatically, balancing regulatory expectations, system risks, and efficient project execution.
• Preferred: Experience evaluating, qualifying, or validating AI-enabled applications, particularly in GxP-regulated environments, including developing strategies to assess reliability, consistency, and fitness for intended use.
• Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related discipline.
• Work Arrangement: Ability to commute to Bridgewater, NJ, and provide onsite support when project activities require it, including multiple days within a given week.