Validation Engineer

Jacobs Management Group • Libertyville, IL

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About The Position

The Validation Engineer will join an established medical device manufacturer in Libertyville, Illinois. This hands-on engineering role is responsible for ensuring manufacturing equipment, processes, and quality systems meet regulatory standards. The engineer will work with Engineering, Manufacturing, and Quality teams to support continuous improvement, new product development, and operational excellence. The position is full-time, with a stated compensation range of $90,000 to $110,000 and a target base salary of $100,000.

Requirements

• 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.
• Experience working with electronic Quality Management Systems.
• Strong analytical, troubleshooting, technical writing, and cross-functional communication skills.

Nice To Haves

• Experience in medical device or pharmaceutical manufacturing.
• Experience with ISO 14971 risk management and design controls.
• Experience with QT9 QMS software.
• Experience with Blow-Fill-Seal (BFS) manufacturing processes.
• Experience with CAPA, nonconformance investigations, and change control.

Responsibilities

• 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.

Benefits

• Career growth and the opportunity to expand expertise in regulated manufacturing, equipment validation, and quality systems.
• Cross-functional exposure through collaboration with Engineering, Manufacturing, Quality, and Product Development.
• Technical ownership of critical validation and calibration activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior