Senior Process Engineer
Current-Led development of redesign of front half of production process and the equipment required for the processing of biologically derived tissue. Reduction of labor by 60%, yield improvement of 25%, yearly cost savings of approximately $1M.-Reduced nuisance alarms of SCADA system by 96% and redesigned reports and notifications to improve user response/documentation time to within process requirements. -Led implementation of risk based calibration program following ISPE GAMP good practice guide "A Risk Based Approach to Calibration Management", reducing incidence of calibration failures by 62%-Performed statistical analysis and simulations for redesigning sampling plans and routine process monitoring-In charge of monthly and annual process monitoring and preliminary data analysis of excursions-Performed root cause analysis of equipment and process in areas that included: mass and energy flow, chemical stability, microbial contamination, electrical, mechanics.-Wrote and executed equipment commissioning, qualification, and process validation documents-Designed and built equipment, setups, and controls for proof of concept/feasibility, experiments, characterization, root cause analysis, etc.-Trained operators and engineering technicians as needed
