Note: The job is a remote job and is open to candidates in USA. Cognizant is a technology and engineering company seeking a Validation Test Engineer – Lab Instrumentation/Medical Devices. The role involves ensuring laboratory instrumentation software is validated and compliant with regulatory standards while collaborating with various stakeholders to drive compliance and operational excellence.
Responsibilities
- Validate and document software installed on laboratory instruments in accordance with EMA regulatory standards
- Migrate instrument software management processes to align with PPD IT SOPs
- Capture, document, and maintain software requirements and configurations
- Develop and execute validation test cases, protocols, and lifecycle documentation for instruments and medical devices
- Perform risk assessments and create infrastructure and data flow diagrams while collaborating with cross-functional teams
Skills
- 6+ years of experience in instrument or medical device validation within a regulated (GxP) environment
- Strong knowledge of validation lifecycle, including test case development and execution
- Proven experience working with EMA guidelines and IT SOPs in pharmaceutical or medical device settings
- Expertise in risk assessment methodologies and compliance-focused documentation
- Strong communication and technical writing skills, with the ability to collaborate across cross-functional teams
- Prior experience in laboratory instrumentation software validation
- Experience creating infrastructure and data flow diagrams
- Hands-on experience aligning validation processes with enterprise IT frameworks
- High attention to detail with a strong focus on compliance and accuracy
- Ability to work effectively in complex, cross-functional project environments
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
Company Overview