Capgemini · 3 weeks ago
Test Validation Lead
Chicago, IL
Full-time
Onsite
Senior Level
$87K/yr - $192K/yrCapgemini is a global business and technology transformation partner, and they are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives. The role involves planning and leading CSV activities, defining validation artifacts, and ensuring compliance with Good Documentation Practices (GDP).
ConsultingInformation TechnologyInsurTechIT ManagementSoftware
Responsibilities
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)
Qualification
Required
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
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
Company
Capgemini
Capgemini is a software company that provides consulting, technology, and digital transformation services.
Founded in 1967
10001+ employees
H1B Sponsorship
Capgemini has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2856)
2024 (3012)
2023 (3424)
2022 (4392)
2021 (3311)
2020 (5871)
Funding
Current Stage
Public CompanyTotal Funding
$4.72B2025-09-18Post Ipo Debt· $4.72B
1999-04-01IPO
Leadership Team
Aiman Ezzat
CEO, Capgemini Group
Anirban Bose
CEO of Americas Strategic Business Unit
Recent News
Business Wire
2026-01-19
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