About the role
As a Senior Validation Test Lead – Lab Instrumentation / Medical Devices, you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the quality and compliance team and work collaboratively with cross-functional stakeholders, including regulatory affairs, engineering, and client teams.
In this role, you will:
• Lead the development and execution of validation and testing strategies for regulated software systems
• Document and validate instrument software in accordance with EMA guidelines and GxP requirements
• Perform risk assessments and proactively communicate risks to stakeholders
• Develop validation test cases, software specifications, and supporting documentation (including infrastructure and data flow diagrams)
• Collaborate with cross-functional teams to ensure seamless integration of compliance requirements
Work model
At Cognizant, we strive to provide flexibility wherever possible and support a healthy work-life balance through various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring full-time presence at a client or Cognizant office in Highland Heights, Kentucky.
The working arrangements for this role are accurate as of the date of posting. This may change based on project and business requirements.
What you need to have to be considered
• Proven lead-level experience in lab instrumentation or medical device software validation within a regulated (GxP) environment
• Strong knowledge of EMA guidelines, validation lifecycle, and compliance standards
• Expertise in technical documentation, validation test case creation, and specification writing
• Experience conducting risk assessments and validation lifecycle documentation
• Strong communication and stakeholder management skills across cross-functional teams
These will help you stand out
• Experience in pharmaceutical or medical device industry environments
• Familiarity with IT SOPs and regulatory audit readiness
• Proven ability to lead teams and mentor members in validation best practices
• Experience driving process improvements in testing frameworks and tools
• Exposure to automation or innovative testing approaches in regulated 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*
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 (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
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.
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.