Test Validation Lead

About the job you’re considering

We are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives

Work Arrangement: On-site at client office in Chicago at least 4 days per week

Your role

• Plan & lead CSV activities for new implementations, enhancements, and periodic reviews, applying risk‑based validation tailored to system criticality.
• Define and deliver validation artifacts, including Validation Plans, IQ/OQ/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports.
• Establish and enforce traceability practices from requirements through testing and release; manage deviations, CAPAs, and re‑tests.
• Execute and oversee testing using HP ALM/Quality Center; track defects and results, assure coverage and objective evidence.
• Ensure documentation meets Good Documentation Practices (GDP)

Your skills and experience

• Computer System Validation (CSV) expertise, including hands‑on IQ/OQ/PQ execution and risk‑based validation approaches.
• Strong working knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Proficiency with validation and testing tools: HP ALM/Quality Center, Veeva Vault (Quality/Docs), CodeBeamer (ALM), and Jira.
• Solid understanding of SDLC and Agile methodologies, with rigorous traceability practices from requirements to release.
• Excellent documentation and compliance skills ensuring GDP adherence; proven audit readiness and inspection support.
• Strong analytical, problem‑solving, and communication abilities to engage stakeholders, synthesize complex issues, and drive resolution.
• Background in life sciences QA/IT/Validation; knowledge of Annex 15, ICH Q9/Q10, and related guidance will be an added advantage.

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to
engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion.

Get the future you want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, R