Architect - GENART

Job Title: Instrument Software validation Engineer Location- Remote (Travel required on and needed basis to KY) Duration: Thru 12/31/2026 Bill Rate: $80/hr. Key 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. Required Skills & Qualifications: • 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. What are the top 3 skills required for this role? 1.Insturment / Medical devices software validation 2. Instrument integration and downstream workflow validation 3. Document and validate software installed on lab instruments per EMA regulatory standards 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.