Validation Engineer

Responsibilities:

Lead validation efforts for injection molding machines, auxiliary equipment (e.g., dryers, chillers, robots), and integrated automation systems.
Develop and execute validation protocols (SAT, FAT, IQ, OQ, PQ) for molding and downstream equipment.
Support the qualification of new production lines involving injection-molded components.
Perform process characterization, capability studies, and stability testing for moulded parts.
Collaborate with tooling, manufacturing, and quality teams to troubleshoot process issues and support process optimization.
Prepare and maintain validation documentation, including risk assessments, protocols, and summary reports.
Conduct temperature/humidity mapping of controlled areas and qualification of cleanroom equipment as needed.
Coordinate activities across both Buffalo Grove and Libertyville facilities to support project milestones.

Requirements:

5+ years of validation experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
Direct experience with injection molding validation, including equipment qualification, process validation, and part testing.
Proficiency with automated manufacturing systems, including HMI/PLC controls.
Strong understanding of cGMP, FDA 21 CFR Part 11, ISO 13485, and GAMP 5 guidelines.
Demonstrated ability to work independently and manage multiple validation projects across facilities.
Experience with cleanroom and environmental system validation (ISO Class 69)'
Familiarity with SCADA systems, data loggers, and equipment calibration tools.
Experience validating downstream automation equipment such as conveyors, vision systems, or packaging lines.
Bachelor's degree in engineering, Plastics Engineering, Mechanical Engineering, or related technical field.