CSV Specialist - AI-enabled systems

Capgemini • Atlanta, GA

5d • $82,082 - $193,440 • Remote

About The Position

The CSV AI Specialist is responsible for supporting the validation and compliance of AI-enabled systems within regulated environments. This role assists in executing Computer System Validation (CSV) activities, ensuring adherence to GxP regulations, quality standards, and organizational validation procedures. The specialist works closely with quality, validation, business, and technology teams to maintain audit-ready documentation, perform risk-based testing, and contribute to continuous improvement of AI system validation practices.

Requirements

• 5+ years of experience in Computer System Validation (CSV), Quality Assurance, or regulated system validation environments.
• Strong understanding of GxP regulations, FDA 21 CFR Part 11, GAMP 5, and other applicable compliance frameworks.
• Experience supporting validation lifecycle activities including requirements review, risk assessment, testing, defect management, and documentation.
• Knowledge of AI/ML systems, software validation principles, and regulatory considerations for AI-enabled solutions.
• Proven ability to create, maintain, and review validation documentation, compliance records, and audit evidence.
• Strong analytical, communication, and stakeholder management skills with the ability to work effectively in cross-functional teams.

Responsibilities

• Support the planning, execution, and documentation of validation activities for AI-enabled applications and systems.
• Assist in the development and maintenance of AI validation compliance procedures, templates, and validation deliverables.
• Ensure AI systems comply with GxP requirements, regulatory expectations, and industry best practices.
• Prepare, review, and maintain audit-ready validation documentation, test evidence, traceability matrices, and compliance records.
• Execute validation activities in accordance with approved Standard Operating Procedures (SOPs) and established validation frameworks.
• Perform risk-based testing, quality reviews, and validation assessments to identify and mitigate compliance risks.
• Contribute to continuous improvement initiatives by enhancing AI validation processes, test methodologies, and quality practices.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed