About the role

As an Validation Specialist in Instrument & Medical Devices, 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 & Compliance team and work collaboratively with cross-functional stakeholders including IT, QA, and lab operations to support a critical validation initiative.

In this role, you will:

· Document and 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 and configurations.

· Develop validation test cases and protocols for instruments and medical devices.

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

· Conduct comprehensive risk assessments.

· Collaborate with internal teams to ensure compliance and documentation accuracy.

Work model:

This is an onsite position requiring presence at the client location in Highland Heights, Kentucky, USA. 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.

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:

· Extensive experience in instrument or 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 ability to work with cross-functional teams.

· High attention to detail with a focus on compliance and accuracy.

These will help you stand out:

· Prior experience in lab instrumentation software validation.

· Ability to work independently and manage multiple validation tasks simultaneously.

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

· 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.

The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.

• Cognizant is a global community with more than 300,000 associates around the world.
• We don’t just dream of a better way – we make it happen.
• We take care of our people, clients, company, communities and climate by doing what’s right.
• We foster an innovative environment where you can build the career path that’s right for you.

About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2025) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com

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.

If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email CareersNA2@cognizant.com with your request and contact information.

Disclaimer:
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.