Location

This is a remote role.

About the job you're considering

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.

Your role

• 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.

Your skills and experience

• 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.

The base compensation range for this role in the posted location is $82,082 - $193,440.

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

• 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

Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.