Engineering Intern
Dayton, New Jersey, United States
1. Managed the calibration and validation of over 50 types of equipment in strict compliance with FDA/DEA standards, significantly enhancing operational reliability and quality adherence.2. Developed and implemented a Blue Mountain software-based calibration forecasting system, increasing scheduling efficiency by 5% and reducing equipment downtime, thereby mitigating potential regulatory issues.3. Led the Installation, Operational, and Performance Qualification (IOPQ) for new equipment, boosting reliability by 10% and ensuring regulatory compliance with the help of QA and manufacturing teams.4. Created protocols for equipment in the manufacturing of 14 key injectables, collaborating with the Quality Assurance Department to ensure high-quality production standards.5. Proactively identified and resolved issues during manufacturing, including equipment malfunctions and deviations from standard operating procedures, maintaining operational excellence.