Process Engineer III- Inspection

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com 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