Senior Validation Test Engineer (Instrument/Medical Device)

Senior Validation Test Engineer (Instrument/Medical Device)

We are seeking a Senior Validation Test Engineer to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines. The ideal candidate will have strong Instrument/Medical device validation experience and will be crucial to ensure compliance, documentation accuracy, and alignment with the 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.

Location: Highland Heights, Kentucky, USA

What you must have to be considered:

• 8+ years of extensive experience in instrument or medical device validation within a regulated (GxP) environment.
• Strong technical writing skills for documentation and test case development.
• Excellent communication skills to interact with cross-functional teams.
• Highly detail-oriented with a focus on compliance and accuracy.
• Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.
• Experience with risk assessment methodologies and validation lifecycle documentation.

These will help you stand out:

• Prior experience in lab instrumentation software validation is highly desirable.

Work model:

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 5 days a week in a client or Cognizant office in Highland Heights, KY.

Note: 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.

In this role, you will:

• Document and validate software installed on lab instruments per EMA regulatory standards.
• Migrate instrument software management to align with PPD IT SOPs.
• Capture and document software requirements and configurations.
• Develop validation test cases and protocols related to Instruments/Medical devices validation.
• Conduct testing and validation of medical devices, including performance testing, reliability testing, and safety testing, to ensure they meet quality standards.
• Prepare and maintain documentation, including technical specifications, test protocols, validation reports, and regulatory submissions, as required by regulatory bodies and quality management systems.
• Create infrastructure and data flow diagrams.
• Conduct comprehensive risk assessments.
• Collaborate with cross-functional teams including IT, QA, and lab operations.

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.

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

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

What we offer:

• The chance to work with impact. Here, you're empowered to bring your biggest thinking to help our company and clients improve everyday life.
• Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
• The opportunity to thrive on a high caliber team with heart. We celebrate each other's experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
• A comprehensive total rewards package, including a competitive salary and pension plan with matching contributions.
• Flexible health and financial benefits to support you and your eligible dependents from day one.
• True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.

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.

Other employment-related information 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, provincial 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.

Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you'll deliver services to and collaborate with stakeholders outside the province who may not speak French.