Test Validation Lead

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About the job you’re considering

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

• 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), 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.

• Paid time off based on employee grade (A‑F):
  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.

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. 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, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini…