Lockport, Illinois, United States
Develop and execute validation protocols (IQ, OQ, PQ), manage calibration program, process engineering, manage environmental monitoring program, develop and validate sterilization processes (steam, irradiation), packaging processes, aseptic fill processes.
Plan, develop, execute and document all activities related to process development and validation (IQ/OQ/PQ) of equipment, processes and software to assure compliance with FDA GMP, USP, ISO internal and external requirements and regulations. Included process development and validation of sterilization processes (steam, e-beam, gamma), water purification systems, clean rooms, aseptic fill processes, bottle packaging, package sealing processes, incubators, ambient and cold storage environments, freezers, lab and production testing equipment and support software. Developed and managed systems and database for calibration of all measurement system equipment within facility. Included strategic outsourcing of calibrations to maximize operational efficiency and development/execution of internally performed calibrations to meet critical needs of facility. Developed, installed, validated and performed ongoing maintenance of USP compliant water purification system. Planned, installed and managed RF/computer based environmental monitoring system (temperature, humidity, pressures) to continuously monitor all environmental processes, alarm for critical deviations and assure prompt and effective corrective actions. Completed projects to upgrade and validate bulk sterilization systems to Fo based processing to achieve more consistent processes and reduce defects related to excess heat heat/oxidation interactions. Specified, developed, installed, validated and maintained new packaging systems to significantly reduce manual labor, increase product quality and increase operational efficiency by 500%+.
As full time 6-Sigma / Lean Blackbelt and Project Engineer completed projects aimed at reducing defect rates and maximizing operational efficiency. Included projects that eliminated critical defects, improved utilization, reduced labor and resulted in 300%+ gain in efficiency. As Senior Quality Engineer developed improved medical device product package testing systems and methods to improve quality, reduce product acceptance lead times, reduce indirect labor and increase efficiencies. Included work with FDA/ISO/ASTM and other medical packaging manufacturers to develop industry standard test methods. As Quality Engineer developed and installed computer based Laboratory Information Management System and test methods/sampling plans integrated with other scheduling and resource management systems to automate data collection of inspection and test data, automated SPC implementation and improve efficiency of product release. As Systems Coordinator installed computer systems (PC Network and AS/400 midrange systems) and developed application software for engineering, production management and planning/material resources support. As Production Supervisor supervised 25+ personnel in production extrusions and packaging line production operations.
General quality engineering including supplier quality and in-process manufacturing support, calibration management, develop and execute validation protocols, control plans, regulatory compliance initiatives, statistical process control, design of experiments, 6-sigma blackbelt projects.