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Instrument Software validation Engineer
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-07-22
Listing for:
TechDigital Group
Full Time
position Listed on 2026-07-22
Job specializations:
-
Engineering
Biomedical Engineer
Job Description & How to Apply Below
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.
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.
- Insturment / 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.
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