CSV Specialist – AI-enabled systems

Capgemini

. Support the planning, execution, and documentation of validation activities for AI-enabled applications and systems .

Posted 9/17/2026full-timeRemote • United StatesMid-LevelSenior💰 $82,082 - $193,440 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer System Validation (CSV) and compliance with GxP regulations, including FDA 21 CFR Part 11 and GAMP 5. Proficient in developing validation documentation and executing validation activities in AI-enabled applications and systems.

Highest-signal resume keywords

Computer System Validation (CSV)GxP RegulationsFDA 21 CFR Part 11AI/ML Systems ValidationValidation Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Lifecycle ActivitiesRisk AssessmentTestingDefect ManagementQuality Assurance

Soft Skills

Analytical SkillsCommunication SkillsStakeholder ManagementCross-Functional Team Collaboration

Tools & Technologies

Standard Operating Procedures (SOPs)Validation FrameworksTraceability Matrices

Industry Keywords

Regulatory ComplianceValidation AssessmentsAudit-Ready DocumentationContinuous ImprovementQuality Practices

About the role

Key responsibilities & impact

Support the planning, execution, and documentation of validation activities for AI-enabled applications and systems
Assist in developing and maintaining 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 according to 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
Work closely with quality, validation, business, and technology teams

Requirements

What you’ll need

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

Benefits

Comp & perks

Paid time off based on employee grade: 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
Additional compensation such as variable incentives, bonuses, or commissions may be available depending on the position and applicable laws
Reasonable accommodations during the recruitment process