About the role
As a Validation Test Engineer – Lab Instrumentation/Medical Devices, you will make an impact by ensuring laboratory instrumentation software is validated and compliant with regulatory standards, contributing to high-quality and audit-ready systems. You will be a valued member of the validation team and work collaboratively with IT, Quality Assurance, and laboratory operations stakeholders to drive compliance and operational excellence.
In this role, you will:
• Validate and document software installed on laboratory instruments in accordance with EMA regulatory standards
• Migrate instrument software management processes to align with PPD IT SOPs
• Capture, document, and maintain software requirements and configurations
• Develop and execute validation test cases, protocols, and lifecycle documentation for instruments and medical devices
• Perform risk assessments and create infrastructure and data flow diagrams while collaborating with cross-functional teams
Work model: Onsite
At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance through our various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring presence in a client or Cognizant office in Highland Heights, Kentucky, USA.
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
• 6+ years of experience in instrument or medical device validation within a regulated (GxP) environment
• Strong knowledge of validation lifecycle, including test case development and execution
• Proven experience working with EMA guidelines and IT SOPs in pharmaceutical or medical device settings
• Expertise in risk assessment methodologies and compliance-focused documentation
• Strong communication and technical writing skills, with the ability to collaborate across cross-functional teams
These will help you stand out
• Prior experience in laboratory instrumentation software validation
• Experience creating infrastructure and data flow diagrams
• Hands-on experience aligning validation processes with enterprise IT frameworks
• High attention to detail with a strong focus on compliance and accuracy
• Ability to work effectively in complex, cross-functional project environments
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*
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。
