Validation Test Lead – Lab Instrumentation/Medical Devices
Listed on 2026-06-04
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IT/Tech
Data Analyst, Systems Analyst
About The Role
As a 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.
- 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
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.
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
- 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
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*
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