Computer System Validation; CSV Lead

About the Role

As a Computer System Validation (CSV) Lead
, you will make an impact by leading validation and testing activities for regulated systems while ensuring compliance with industry standards, quality requirements, and customer-approved processes. You will be a valued member of the project delivery team and will collaborate closely with business stakeholders, quality teams, project managers, and technical teams to deliver compliant and high‑quality validation outcomes.

• Lead validation testing activities, including test strategy development, test design, execution, and reporting.
• Apply GAMP categorization, CSV/CSA methodologies, 21 CFR Part 11 requirements, and risk‑based validation approaches to validation programs.
• Analyze functional requirements, estimate testing efforts, and contribute to project planning and validation strategies.
• Support the preparation, review, and maintenance of testing and Software Lifecycle (SLC) documentation.
• Execute validation activities in accordance with approved processes, procedures, compliance requirements, and training standards.
• Coordinate defect triage activities, analyze test results, and collaborate with cross‑functional teams to resolve issues.
• Monitor testing progress and provide accurate daily, weekly, and monthly status updates to stakeholders.
• Ensure timely delivery of quality validation outcomes while maintaining compliance with regulatory and organizational standards.

We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants within the United States. Candidates located in or near Waukegan, IL, or those willing to work periodically from the client office in Waukegan, are strongly preferred. Regardless of your working arrangement, we are here to support a healthy work‑life balance through our various wellbeing programs.

• Strong understanding of GAMP categorization, Computer System Validation (CSV), Computer Software Assurance (CSA), and 21 CFR Part 11 requirements.
• Experience applying risk‑based validation approaches and developing validation strategies for regulated environments.
• Hands‑on experience with validation test planning, test design, execution, defect management, and reporting.
• Ability to analyze business and functional requirements and translate them into validation deliverables.
• Experience creating and maintaining testing and Software Lifecycle (SLC) documentation.
• Strong stakeholder management and collaboration skills with the ability to work across cross‑functional teams.
• Excellent communication skills with experience providing project and testing status updates to leadership and stakeholders.
• Proven ability to deliver high‑quality validation outcomes within established timelines.

• Experience supporting Life Sciences, Pharmaceutical, Biotechnology, or other regulated industry programs.
• Knowledge of GxP compliance requirements and regulatory expectations.
• Experience leading validation activities across multiple projects or work streams.
• Familiarity with validation automation, test management, and defect tracking tools.
• Strong analytical, problem‑solving, and risk‑assessment capabilities.

We’re excited to meet people who share our mission and can make an impact in a variety of ways. Don’t hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Applications will be accepted until July 10, 2026.

The annual salary for this position is between $83,250–$131,500 depending on experience and other qualifications of the successful candidate.

This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.

• Medical/Dental/Vision/Life Insurance
• Paid holidays plus Paid Time Off
• 401(k) plan and contributions
• Long‑term/Short‑term Disability
• Paid Parental Leave
• Employee Stock Purchase Plan

Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.
* Please note, this role is not able to offer visa transfer or sponsorship now or in the future*