Lab Equipment Validation Engineer
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Job Location:
Round Lake, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Role : Lab Equipment Validation Engineer
Location : Round Lake IL onsite
Job Summary
Baxter Healthcare Round Lake is seeking a highly skilled and experienced Lab Equipment Validation Engineer to support the Infusion Systems organization. The ideal candidate will be responsible for validating laboratory equipment used for infusion system testing including Infuscale systems altitude chambers environmental chambers and other specialized test equipment. This role requires strong expertise in equipment validation deep understanding of infusion system test methodologies and experience working within FDA regulated medical device environments. The engineer will ensure that all lab equipment used for verification and performance testing complies with applicable regulatory and quality standards.
Key ResponsibilitiesLead validation efforts for laboratory equipment supporting infusion system testing (e.g. 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/PQ activities for lab equipment and ensure complete traceability from requirements through test execution.
- Ensure validated equipment supports all infusion system verification needs including flow accuracy environmental stress testing and performance simulation.
- Collaborate with hardware firmware and systems engineering teams to ensure equipment suitability and proper test coverage.
- Investigate and resolve equipment issues discovered during validation or testing activities.
- Support calibration maintenance and lifecycle management of lab equipment used for infusion system tests.
- Drive continuous improvement of validation processes documentation quality and lab test methodologies.
- Maintain accurate and compliant documentation per Baxter quality systems design control and equipment lifecycle standards.
Qualifications
- Bachelors or Masters degree in Electrical Engineering Biomedical Engineering Mechanical Engineering Computer Engineering or related technical field.
- Minimum 5 years of experience in equipment validation or software validation within a medical device or FDA regulated environment.
- Strong understanding of FDA regulations ISO 13485 equipment validation and regulated testing processes.
Hands on experience with:
- Lab equipment used in infusion system testing: Infuscale altitude chambers environmental chambers flow measurement instruments and similar test systems.
- Tools such as LabVIEW or Python for automating test data acquisition (as applicable).
- Test measurement instruments such as temperature chambers flow analyzers pressure sensors oscilloscopes and calibration tools.
- Risk management frameworks (ISO 14971).
- Working within formal document control change management and validation documentation systems.
Preferred Qualifications
- Prior experience validating lab equipment specifically for infusion systems or drug delivery devices.
- Knowledge of environmental and stress testing methodologies for medical device performance verification.
- Familiarity with data integrity and cybersecurity considerations in lab test environments.
- Certifications such as CSQE CMII or Lean Six Sigma are a plus
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
