Instrument Software validation Engineer

TechDigital Group; North Carolina; Hybrid; USD 90,000 - 150,000; Full time

Job summary

TechDigital Group seeks an experienced Senior Instrument/Medical Device Validation specialist to lead validation efforts for lab instruments and integrations in a GMP/GxP setting.

You will document requirements, develop test protocols, and ensure alignment with EMA guidelines and IT SOPs, collaborating with IT, QA, and lab operations across cross-functional teams in North Carolina. This role offers growth in a regulated environment with impactful projects.

Qualifications

• Proven experience in Instrument/Medical device validation within a regulated (GxP) environment.
• Strong technical writing for documentation and test case development.
• Excellent cross-functional communication with IT, QA, and lab operations.
• Familiarity with EMA guidelines and IT SOPs in pharma or medical devices.

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

Instrument/Medical device validation

Instrument integration

Downstream workflow validation

Technical writing

Job description

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.

Top 3 Skills Required

• Insturment / Medical devices software validation
• Instrument integration and downstream workflow validation
• 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.