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changing the way medicine is made
. We're building a sustainable network of high-tech, end-to-end manufacturing solutions
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Position Summary
The Process Engineer III - Inspection is a mid-level technical leader responsible for the reliability, performance, validation, and inspection readiness of automated inspection equipment within a GMP-regulated manufacturing environment.
This role owns the overall strategy for automated vision and inspection systems, drives long-term performance improvements, and serves as the primary technical contact for inspection-related issues impacting product quality, compliance, and throughput. The position partners cross-functionally with Manufacturing, Maintenance, Quality, Validation, Regulatory, Technical Operations, and Facilities to ensure compliant, capable, and inspection-ready systems.
Position Responsibilities
Equipment Reliability & Technical Leadership
- Own reliability strategy for automated inspection systems, ensuring sustained performance against established KPIs (OEE, False Rejects, Defect Rates, MTBF, MTTR, downtime).
- Develop and maintain preventive and predictive maintenance strategies for inspection equipment, including vision systems, cameras, sensors, and reject mechanisms.
- Analyze performance, reject rate data and trends to identify failure modes, implement corrective and preventive actions, and implement vision recipe improvements.
- Lead complex troubleshooting efforts for mechanical, electrical, controls, and vision-related issues.
- Serve as the technical subject matter expert (SME) for automated inspection system.
- Provide mentorship and technical guidance to engineering, maintenance, and operations teams.
- Provide on-call technical support as required.
Validation, Compliance & Inspection Readiness
- Ensure automated inspection systems remain in a validated and inspection-ready state in accordance with FDA and global regulatory expectations.
- Author and/or approve URS, FAT/SAT protocols, commissioning documentation, and IQ/OQ/PQ protocols and reports related to inspection equipment.
- Support validation lifecycle activities, including revalidation following changes or performance drift.
- Lead technical investigations for inspection-related deviations, non-conformances, and customer complaints.
- Support Change Control activities, ensuring appropriate risk assessments and validation impact evaluations.
- Serve as inspection equipment SME during regulatory inspections and internal audits.
Continuous Improvement & Asset Strategy
- Lead long-term reliability and performance improvement initiatives focused on:
- False reject reduction
- Detection capability optimization
- Equipment downtime reduction
- OEE improvement
- Obsolescence management
- Inspection process improvements (i.e. SOR/EOR)
- Implement data-driven monitoring strategies and statistical analysis to ensure sustained inspection effectiveness.
- Support new equipment installations, upgrades, and lifecycle planning.
- Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
Minimum Qualifications
Significant experience supporting automated inspection or vision systems in a GMP-regulated manufacturing environment.
Experience with equipment validation (IQ/OQ/PQ) and lifecycle management.
Experience leading