2 дня назад
Process Engineer III - Inspection (Biomanufacturing)
80 000 - 121 250$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Engineer III - Inspection (Biomanufacturing): Maintaining and improving automated vision and inspection systems in a GMP-regulated manufacturing environment with an accent on equipment reliability, validation, compliance, and inspection readiness. Focus on reducing false rejects and downtime, optimizing detection capability and OEE, leading technical investigations, and managing validation and lifecycle activities.
Location: USA - OH - West Chester
Salary: $80,000–$121,250 per year
Company
is a technology-focused biomanufacturing company developing high-tech, end-to-end manufacturing solutions.
What you will do
- Own the reliability strategy for automated inspection systems, including vision systems, cameras, sensors, and reject mechanisms.
- Analyze performance and reject-rate data, identify failure modes, improve vision recipes, and implement corrective and preventive actions.
- Lead troubleshooting of mechanical, electrical, controls, and vision-related issues and provide technical guidance to engineering, maintenance, and operations teams.
- Maintain validated and inspection-ready systems and author or approve URS, FAT/SAT, commissioning, and IQ/OQ/PQ documentation.
- Lead investigations into deviations, non-conformances, and customer complaints while supporting change control and regulatory inspections.
- Drive improvements in false rejects, detection capability, downtime, OEE, obsolescence management, and inspection processes.
Requirements
- Significant experience supporting automated inspection or vision systems in a GMP-regulated manufacturing environment.
- Experience with equipment validation, including IQ/OQ/PQ, and equipment lifecycle management.
- Experience leading technical investigations, root cause analysis, and change control processes.
- Strong understanding of equipment reliability principles, including MTBF, MTTR, FMEA, and risk management.
- Bachelor’s degree in Mechanical, Electrical, Controls, Biomedical, or related engineering discipline is preferred.
- Work authorization or visa sponsorship is not available for this position.
Nice to have
- Experience with camera-based inspection platforms and PLC or controls troubleshooting.
- Experience supporting regulatory inspections, CMMS systems, and reliability analytics.
- Project management experience in capital or long-term reliability initiatives.
- Lean Manufacturing or Six Sigma certification.
Culture & Benefits
- Annual cash bonus program and 401(k) plan with company match.
- Medical, dental, and vision healthcare benefits.
- Paid vacation, paid holidays, and other paid leaves of absence.
- Family-building benefits, life and disability insurance, and caregiving support.
- Tuition reimbursement.
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