Validation Engineer

Reqroute, Inc is seeking an Instrument Software Validation Engineer. The role involves documenting and validating software for lab instruments in compliance with EMA regulatory standards, as well as collaborating with cross-functional teams to ensure proper validation processes are followed.

Responsibilities:

• Document and validate software installed on lab instruments per EMA regulatory standards
• Validate Instruments and Instrument Integration
• 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, integrations and downstream workflow validation
• Create infrastructure and data flow diagrams
• Conduct comprehensive risk assessments
• Collaborate with cross-functional teams including IT, QA, and lab operations

Requirements:

• Proven experience in Instrument/Medical device validation along with integrations and downstream workflows 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
• Instrument / Medical devices software validation
• Instrument integration and downstream workflow validation
• Document and validate software installed on lab instruments per EMA regulatory standards
• Mid to Senior Level professionals with 6–10+ years of relevant experience
• Prior experience in lab instrumentation software validation is highly desirable