Test Validation Lead

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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.

• 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)

• 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), Code Beamer (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.

The base compensation range for this role in the posted location is $86,900 - $192,460.

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…