Capgemini
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
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. With more than 340,000 team members across 50+ countries and a 55‑year heritage, Capgemini is trusted to unlock the value of technology across the entire breadth of business needs.
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. Capgemini is committed to providing reasonable accommodations during the recruitment process. Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.
Schedule
Full‑time
Primary Location
US-IL-Chicago
Organization
NA APPS LOC PRACTICE
#J-18808-Ljbffr
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
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. With more than 340,000 team members across 50+ countries and a 55‑year heritage, Capgemini is trusted to unlock the value of technology across the entire breadth of business needs.
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. Capgemini is committed to providing reasonable accommodations during the recruitment process. Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.
Schedule
Full‑time
Primary Location
US-IL-Chicago
Organization
NA APPS LOC PRACTICE
#J-18808-Ljbffr