Process Engineer III- Inspection

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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.

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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 technical investigations, root cause analysis, and change control processes.

• Strong understanding of equipment reliability principles (MTBF, MTTR, FMEA, risk management).

Preferred Qualifications

• 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.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.