Instrument Software validation EngineerLocation- Remote (Travel required on and needed basis to KY)Key Responsibilit ies:• 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.Required Skills & Qualificat ions:Proven experience in Instrument/Medical device validation along with integrations and downstream workflows within a regulated (GxP) environmentStrong technical writing skills for documentation and test case developmentExcellent communication skills to interact with cross-functional teamsHighly detail-oriented with a focus on compliance and accuracyFamiliarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settingsExperience with risk assessment methodologies and validation lifecycle documentation.Years of experience required: Mid to Senior Level professionals with 6–10+ years of relevant experience. Prior experience in lab instrumentation software validation is highly desirable.

Instrument Software Validation Engineer

Emma

Requirements and responsibilities

Skills wanted:

Language(s) required:

About Smart IT Frame LLC:

www.smartitframe.com/

Admin access needed