Process Engineer III- Inspection

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.

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.

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.

• 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 technical investigations, root cause analysis, and change control processes.
• Strong understanding of equipment reliability principles (MTBF, MTTR, FMEA, risk management).

• Bachelor's degree in engineering (Mechanical, Electrical, Controls, Biomedical, or related discipline).
• Experience with automated vision systems, camera-based inspection platforms, and PLC/controls troubleshooting.
• Experience supporting regulatory inspections.
• Experience with CMMS systems and reliability analytics.
• Project management experience in capital or long-term reliability initiatives.
• Lean Manufacturing or Six Sigma certification.

Resilience is an Equal Employment…