Process Engineer III- Inspection
About The Position
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.
Requirements
- 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).
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
