Validation Engineer - Rockford
1 day ago

Job description
Position OverviewWe are seeking an experienced Validation Engineer to support GMP-regulated manufacturing operations in Rockford, IL.
This role will focus on equipment and process validation activities for automated and high-speed assembly systems within a medical device or combination product environment.
The ideal candidate will have strong hands-on experience in IQ/OQ/PQ execution, deviation investigations, and technical documentation within a GMP framework.
Key ResponsibilitiesLead and execute validation activities for manufacturing equipment, including automated and high-speed assembly lines
Develop, review, and execute IQ/OQ/PQ protocols and reports in compliance with GMP requirements
Support equipment commissioning and process validation activities
Perform risk assessments and ensure alignment with validation master plans and project timelines
Investigate deviations, non-conformances, and validation discrepancies; perform root cause analysis and implement corrective actions
Author clear, concise, and technically sound validation documentation
Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Regulatory teams
Ensure compliance with FDA regulations, ISO standards, and internal quality procedures
Provide on-floor validation support during execution windows and troubleshooting activities
Required Qualifications
Bachelor's degree in Engineering or related technical field
3–10 years of GMP validation experience within medical device or combination product manufacturing
Direct hands-on experience writing and executing IQ/OQ/PQ protocols
Experience validating automated assembly systems or high-speed manufacturing lines
Strong deviation investigation, root cause analysis, and technical writing skills
Working knowledge of FDA regulations and ISO 13485 standards
Ability to work independently in a fast-paced, regulated manufacturing environment
Preferred Qualifications
Experience with combination products
Familiarity with risk management tools (FMEA, risk assessments)
Experience supporting remediation or audit-related validation activities
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