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Lab Equipment Validation Engineer
Job in
Round Lake, Lake County, Illinois, 60073, USA
Listed on 2026-03-04
Listing for:
CYNET SYSTEMS
Full Time
position Listed on 2026-03-04
Job specializations:
-
Engineering
Biomedical Engineer, Validation Engineer
Job Description & How to Apply Below
Job Description :
Pay Range: $30hr - $35hr
- The Lab Equipment Validation Engineer will lead validation activities for laboratory equipment supporting infusion system testing.
- This role ensures equipment compliance with FDA and ISO regulations, supports verification and performance testing, and maintains validated lab systems used across R&D and quality operations.
- Lead validation efforts for laboratory equipment supporting infusion system testing, including Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related test systems.
- Develop and execute validation protocols, test plans, and reports in alignment with FDA 21 CFR Part 820, Part 11, ISO 13485, and equipment validation best practices.
- Partner with R&D, Quality, and Systems Engineering teams to define equipment validation requirements and risk-based strategies.
- Perform IQ, OQ, and PQ activities for laboratory equipment with full traceability from requirements through execution.
- Ensure validated equipment supports infusion system verification needs such as flow accuracy, environmental stress testing, and performance simulation.
- Collaborate with hardware, firmware, and systems engineering teams to ensure equipment suitability and test coverage.
- Investigate and resolve equipment issues identified during validation or testing activities.
- Support calibration, maintenance, and lifecycle management of laboratory equipment.
- Drive continuous improvement of validation processes, documentation quality, and laboratory test methodologies.
- Maintain accurate and compliant documentation in accordance with Baxter quality systems, design control, and equipment lifecycle standards.
- Minimum of 5+ years of experience in equipment validation or software validation in an FDA-regulated medical device environment.
- Strong knowledge of FDA regulations, ISO 13485, and equipment validation practices.
- Hands-on experience validating laboratory equipment used in infusion system testing.
- Experience performing IQ, OQ, and PQ activities.
- Experience working within formal document control and change management systems.
- Equipment validation and regulated testing.
- Risk management per ISO 14971.
- Lab equipment qualification and lifecycle management.
- Cross-functional collaboration with engineering and quality teams.
- Experience using LabVIEW or Python for automated test data acquisition.
- Familiarity with test instruments such as temperature chambers, flow analyzers, pressure sensors, oscilloscopes, and calibration tools.
- Bachelor s or Master s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Computer Engineering, or a related technical field.
- Prior experience validating laboratory equipment for infusion systems or drug delivery devices.
- Knowledge of environmental and stress testing methodologies for medical device verification.
- Familiarity with data integrity and cybersecurity considerations in laboratory environments.
- Certifications such as CSQE, CMII, or Lean Six Sigma.
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