About the role
As a Validation Test Analyst (CSV/CSA), you will make an impact by ensuring regulated systems meet compliance, quality, and validation requirements within Life Sciences environments. You will be a valued member of the quality and validation team, collaborating closely with business stakeholders, project teams, testing teams, and regulatory compliance partners to support Computer System Validation (CSV) and Computer Software Assurance (CSA) initiatives.
In this role, you will:
- Execute validation and testing activities in accordance with approved customer processes, procedures, and regulatory requirements.
- Design, develop, and execute validation test scripts and supporting validation deliverables.
- Analyze functional and business requirements, estimate testing efforts, and contribute to validation planning and strategy development.
- Support the preparation, review, and maintenance of testing and Software Lifecycle (SLC) documentation.
- Coordinate defect triage activities, investigate test results, and collaborate with cross-functional teams to drive issue resolution.
- Ensure timely delivery of high-quality validation testing activities while maintaining compliance standards.
- Provide regular project updates and status reporting through daily, weekly, and monthly governance forums.
- Support validation initiatives involving Documentum (OpenText D2) and other regulated platforms.
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 in Chicago-IL. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.
The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.
What you need to have to be considered
- Strong understanding of GAMP categorization, Computer System Validation (CSV), Computer Software Assurance (CSA) methodologies, and validation lifecycle processes.
- Experience working with 21 CFR Part 11 requirements and risk-based validation approaches in regulated environments.
- Hands-on experience with Documentum (OpenText D2).
- Proven experience in validation test design, execution, defect management, and test result analysis.
- Ability to create, review, and maintain validation and Software Lifecycle (SLC) documentation.
- Experience interpreting functional requirements and translating them into effective validation strategies and test scenarios.
- Strong collaboration and communication skills, with experience working across business, quality, and technical teams.
- Experience providing status reporting and managing validation deliverables in a structured project environment.
These will help you stand out
- Experience supporting Life Sciences, Pharmaceutical, Biotechnology, or Medical Device organizations.
- Familiarity with GxP-regulated systems and quality management processes.
- Knowledge of risk assessment methodologies and CSA best practices.
- Experience participating in audits, inspections, or compliance reviews.
- Exposure to Agile delivery methodologies within regulated environments.
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:
The annual salary for this position is between $71,100 to 112,500 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
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
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*
About Cognizant:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
