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

Bridgewater, United States

Job Description

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.