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About the job youu2019re 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 risku2011based 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 reu2011tests. + 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 handsu2011on IQ/OQ/PQ execution and risku2011based 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, problemu2011solving, 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 Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer: + 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, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of u20ac22.1 billion. Get the future you want 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. 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 will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Click the following link for more information on your rights as an Applicant 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. Job: Organization: _NA APPS LOC PRACTICE_ Title: _Test Validation Lead_ Location: _IL-Chicago_ Requisition ID: _082458_