"Please note, this role is not able to offer visa transfer or sponsorship now or in the future."
About the role
As a Computer System Validation (CSV) Consultant, you will make an impact by ensuring regulated computerized systems, laboratory applications, and digital platforms meet compliance, quality, and validation requirements within the pharmaceutical and life sciences industry. You will be a valued member of the Life Sciences team and work collaboratively with quality, validation, testing, regulatory, business, and technology stakeholders to support compliant system implementations and enhancements.
In this role, you will:
- Lead Computer System Validation (CSV) activities for laboratory, enterprise, and regulated business systems in GxP environments.
- Develop and execute validation deliverables including validation plans, requirements documentation, traceability matrices, test protocols, and validation summary reports.
- Partner with business, quality, and technical teams to ensure systems comply with FDA, GAMP, and global regulatory requirements.
- Support system implementations, upgrades, migrations, and remediation initiatives through the full system development lifecycle.
- Provide guidance on validation best practices, regulatory compliance, risk-based validation approaches, and quality management requirements.
Work model
We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a hybrid position requiring attendance at a client or Cognizant office in Boston, MA or San Francisco, CA.
Regardless of your working arrangement, we are here to support a healthy work-life balance through 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
- Experience with Computer System Validation (CSV) in regulated pharmaceutical, biotechnology, or life sciences environments.
- Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP compliance requirements.
- Hands-on experience validating at least one QC, R&D, or laboratory system.
- Experience creating and executing validation documentation including URS, Validation Plans, IQ, OQ, PQ, Traceability Matrix, Test Protocols, and Validation Summary Reports.
- Experience working within SDLC and V-Model validation frameworks.
- Strong technical writing, documentation, and communication skills.
- Experience supporting regulatory audits, inspections, remediation activities, and compliance initiatives.
- Knowledge of testing methodologies and validation execution for regulated systems.
- Ability to collaborate effectively with cross-functional stakeholders.
These will help you stand out
- Experience with Computer Software Assurance (CSA) methodologies and risk-based validation approaches.
- Experience with laboratory automation, process automation, enterprise applications, or network infrastructure validation.
- Experience working in Agile delivery environments.
- Hands-on experience with Jira, ServiceNow, HP ALM, or similar testing and work management tools.
- Experience with test automation frameworks or validation automation tools.
- Interest in or exposure to AI-enabled solutions within regulated environments.
We're excited to meet people who share our mission and who can make an impact in a variety of ways. Don't hesitate to apply—even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out.
Salary and Other Compensation:
Applications will be accepted until Aug 30, 2026,
The annual salary for this position is between $75,000 - $90,000 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.
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。
