- Ex
- Facilitated discussions and planning across multiple departments regarding manufacturing readiness of Tech Transfer batches – including Development, Exhibit, and Process Validation
[Company or College], [City], [State], [Start Date], [End Date], [Title], Ex. Assisted and supervised 30 chemical engineering students in operating and troubleshooting industrial chemical processes equipment (distillation column, heat exchanger, and CSTR reactor) in the Unit Operations Lab
(Ex, Autoclaves, ATEC, Parts Washers, Formulation Tanks, Lab-scale and commercial scale mixers, Isolator Fillers, 3D printers, distillation towers, heat exchanges, reactors, etc), (Ex. AutoCAD, Robotics Design/Control, Medical Device Design/Control, MATLAB, Simulink, SolidWorks, Python, C++, Microsoft Word/Excel/Powerpoint, Process Flow Diagram (PFD) and Piping & Instrumentation Diagram (PID) generation), (Ex. Fluent in Polish, basic working knowledge of Spanish)
Ex. Professional experience in technology transfer, automation/robotics, technical communication, systems testing, verification and troubleshooting equipment. Trained in cGMP Regulations, Medical Device Quality Management Systems, Good Documentation Practices, Electronic Records/Electronic Signatures, Data Integrity, ISPE’s Guidance on Commissioning and Qualification, ICH and FDA Guidelines, Process Validation, and Cleaning Validation. Responsible for writing and executing cGMP Validation Lifecycle documentation in alignment with client quality systems, operating procedures, and industry standards. Excels in organization and problem solving.
Current Title
[Client Site], [City], [State], [Start Date], [End Date], Title, Ex. Facilitated discussions and planning across multiple departments regarding manufacturing readiness of Tech Transfer batches – including Development, Exhibit, and Process Validation