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About the role

As an **Instrument/Medical Device Validation Specialist** , you will make an impact by ensuring software installed on laboratory instruments meets regulatory standards and aligns with internal SOPs. You will be a valued member of the **Quality Engineering and Assurance Team** , collaborating closely with IT, QA, and lab operations to support a critical compliance initiative.

In this role, you will:

+ Validate software installed on lab instruments in accordance with EMA regulatory guidelines.

+ Migrate instrument software management processes to align with PPD IT SOPs.

+ Capture and document software requirements, configurations, and infrastructure.

+ Develop validation test cases, protocols, and risk assessments for lab instrumentation.

+ Create infrastructure and data flow diagrams to support validation efforts.

+ Collaborate with cross-functional teams to ensure documentation accuracy and compliance.

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 2–3 days a week** in a client or Cognizant office in **Highland Heights, Kentucky** . 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

+ 6–10+ years of experience in Instrument/Medical Device validation within a regulated (GxP) environment.

+ Strong technical writing skills for documentation and test case development.

+ Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.

+ Experience with risk assessment methodologies and validation lifecycle documentation.

+ Excellent communication skills and attention to detail.

These will help you stand out

+ Prior experience in lab instrumentation software validation.

+ Ability to create infrastructure and data flow diagrams.

+ Proven success working in cross-functional teams including IT, QA, and lab operations.

+ Deep understanding of compliance and regulatory documentation standards.

+ Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

_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 is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.