Validation Engineer Lab Instrumentation/Medical Devices

About the role As a Validation 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 c ompliance 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

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