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 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*
About us
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge 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, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com 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.
