Process Engineer III- Inspection
Job in
Florence, Boone County, Kentucky, 41022, USA
Listed on 2026-06-06
Listing for:
Resilience
Full Time
position Listed on 2026-06-06
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer
Job Description & How to Apply Below
- Inspection page is loaded## Process Engineer III
- Inspection locations:
USA - OH - West Chester time type:
Full time posted on:
Posted 2 Days Agojob requisition :
R-106660A 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
** 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…
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