Instrument and Medical Devices Validation Analyst

Instrument/Medical Device Validation Specialist

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 23 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:

• 610+ 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

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. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World's Best Employers 2024) is consistently listed among the most admired companies in the world.

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.