Process Development Engineer
Current- Applied working knowledge of FDA and EU guidelines to author and support execution of Process Performance Qualification (PPQ) protocols for an additional cGMP filling site.
- Collaborated with Production staff to identify improvements, address failure areas, and increase overall process confidence. Provided on-call support for Manufacturing teams during bulking and filling operations.
- Identified alternate manufacturing components to increase robustness of bulking process. Reduced business costs and delays by creating a SolidWorks model and utilizing in-house fabrication capabilities.
- Conducted engineering studies to mimic an aseptic manufacturing environment, ensuring ALCOA+, GxP, and gowning practices were followed during processing steps and immediate equipment troubleshooting.