We are looking for a hands-on Validation Engineer with experience in plastic injection molding, equipment qualification, and process validation within a regulated manufacturing environment. The ideal candidate will be responsible for executing IQ/OQ/PQ protocols, qualifying molding equipment, troubleshooting process issues, and ensuring compliance with FDA, ISO 13485, and GMP requirements.
Develop and execute IQ/OQ/PQ protocols for injection molding machines, tooling, automation, and manufacturing equipment.
Lead equipment qualification, process validation, mold qualification, and process characterization activities.
Support new equipment installations, product launches, process transfers, and manufacturing changes.
Perform risk assessments using FMEA/PFMEA and investigate deviations, validation failures, and nonconformances.
Analyze process capability and validation data to improve molding quality, cycle times, and manufacturing efficiency.
Collaborate with Manufacturing Engineering, Quality, Tooling, Automation, and Production teams to resolve technical issues.
Prepare validation protocols, reports, and engineering documentation while supporting CAPA, change control, and regulatory audits.
Participate in equipment FAT/SAT activities and ensure compliance with applicable quality and regulatory standards.
| Location | Buffalo Grove, IL |
| Job Type | Contractor |
| Salary | $35–$40 Per Hour |
Bachelor's degree in Engineering or a related technical field.
3+ years of validation engineering experience in manufacturing.
Hands-on experience with plastic injection molding equipment and process validation.
Strong knowledge of IQ/OQ/PQ, equipment qualification, and process validation documentation.
Familiarity with scientific molding, process optimization, and statistical process capability analysis.
Experience with FMEA/PFMEA, risk assessments, CAPA, and change control.
Knowledge of FDA regulations, ISO 13485, and GMP requirements.
Strong troubleshooting, technical writing, and cross-functional collaboration skills.
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