Process Engineer III- Inspection

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.

Position 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.

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.