Validation Engineer

Location: Libertyville, IL
Compensation: $90,000 to $110,000
Industry: Medical Device Manufacturing
Employment Type: Full-Time

Make an Impact Where Quality and Engineering Come Together

Are you an experienced Validation Engineer who enjoys solving technical challenges, improving manufacturing processes, and ensuring equipment and systems perform at their best?

We're recruiting for a Validation Engineer to join an established medical device manufacturer.

This is a hands-on engineering opportunity where you'll play a critical role in ensuring manufacturing equipment, processes, and quality systems meet stringent regulatory standards. You'll work closely with Engineering, Manufacturing, and Quality teams to drive continuous improvement, support new product development, and maintain a high level of operational excellence.

• Lead equipment, process, and test method validation activities, including developing and executing validation protocols.

• Manage equipment calibration programs, schedules, documentation, and compliance requirements.

• Analyze validation results, investigate deviations, and implement corrective actions.

• Partner with Manufacturing, Engineering, and Quality teams to troubleshoot processes and improve equipment performance.

• Maintain validation records, equipment databases, and calibration certifications within the Quality Management System (QMS).

• Support change control, CAPA, risk management, and new product development initiatives.

• Ensure compliance with FDA regulations, ISO 13485, and applicable GMP requirements.

• Contribute to design control activities and documentation supporting regulatory compliance.

• Bachelor's degree in Engineering or a related technical discipline.

• 5+ years of experience in validation, quality engineering, or quality systems within an FDA-regulated manufacturing environment.

• Experience developing and executing equipment, process, or test method validations.

• Hands-on experience with equipment calibration programs and documentation.

• Working knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP requirements
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• Experience working with electronic Quality Management Systems.

• Strong analytical, troubleshooting, technical writing, and cross-functional communication skills.

• Medical device or pharmaceutical manufacturing.

• ISO 14971 risk management and design controls.

• QT9 QMS software.

• Blow-Fill-Seal (BFS) manufacturing processes.

• CAPA, nonconformance investigations, and change control.

• Meaningful Impact: Your work directly supports the safety, quality, and reliability of medical products.

• Cross-Functional Exposure: Collaborate with Engineering, Manufacturing, Quality, and Product Development.

• Technical Ownership: Take responsibility for critical validation and calibration activities rather than focusing solely on documentation.

• Competitive Compensation: Target base salary of $100,000.

• Career Growth: Expand your expertise in regulated manufacturing, equipment validation, and quality systems.