Validation Engineer
Job in
Rockford, Winnebago County, Illinois, 61103, USA
Listed on 2026-03-08
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-03-08
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
We 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 Responsibilities- Lead 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
- 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
- Experience with combination products
- Familiarity with risk management tools (FMEA, risk assessments)
- Experience supporting remediation or audit-related validation activities
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