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*
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
补充雇佣信息
薪酬信息截至本职位发布之日为准。Cognizant 保留在适用法律允许的范围内随时修改该信息的权利。
申请人可能需要通过现场面试或视频会议的方式参加面试。此外，候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
Cognizant 是一家提供平等就业机会的雇主。在招聘过程中，您的申请和候选资格不会因种族、肤色、性别、宗教、信仰、性取向、性别认同、国籍、残疾、遗传信息、怀孕、退伍军人身份或任何其他受联邦、州或地方法律保护的特征而受到影响。
