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.
In This Role, You Will
• 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.
Work Model
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.
What You Need to Have to Be Considered
• 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.
These Will Help You Stand Out
• 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 workstreams.
• 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.
Salary and Other Compensation:
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.
Benefits:
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
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*
Über Cognizant
Cognizant (NASDAQ: CTSH) i ist ein Technologiedienstleister und Entwickler von KI-Lösungen. Wir schlagen die Brücke zwischen KI-Investitionen und echtem unternehmerischem Mehrwert, indem wir ganzheitliche Full-Stack-KI-Lösungen für unsere Kunden entwickeln. Mit unserer fundierten Branchen-, Prozess- und Engineering-Expertise integrieren wir die spezifischen Anforderungen von Unternehmen passgenau in Technologiesysteme. So entfalten wir das menschliche Potenzial, erzielen greifbare Ergebnisse und sichern globalen Unternehmen in einer sich rasant wandelnden Welt den entscheidenden Vorsprung. Erfahren Sie mehr unter cognizant.ai oder @cognizant.
Zusätzliche Informationen zur Beschäftigung
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