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 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*
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