Test Validation Lead

Capgemini • Chicago, IL

3d • Onsite

About The Position

We are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives. This is an on-site role 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)

Requirements

• 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.

Nice To Haves

• Background in life sciences QA/IT/Validation; knowledge of Annex 15, ICH Q9/Q10, and related guidance will be an added advantage.

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)

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: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees