Instrument Software validation Engineer

TechDigital Group; Town of Texas (WI); Hybrid; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group in Wisconsin is seeking a seasoned professional to lead instrument and medical device software validation, including integrations and downstream workflows, within a GMP/GxP-regulated setting. The role focuses on documenting and validating software on lab instruments per EMA standards and IT SOPs.

The ideal candidate excels in technical writing, cross-functional collaboration with IT, QA, and lab operations, and has strong attention to detail with a solid background in risk

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.

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

Technical writing

Communication skills

Attention to detail

EMA guidelines familiarity

Risk assessment methodologies

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.

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.