Bayer Pharmaceuticals was one of my first experiences working with a Fortune 500 Company and the Regulatory side of Engineering, directly receiving comments from the FDA. I updated Task Analysis reports and FDA 501k pre-submission reports. I also set up protocols for Microbial Ingress testing (Protocols, B/F testing, and Product Quantity Management) and Chemical Integrity Testing according to the USP 788 (Particle matter in injections) infection in sterile disposables. I tested protocols for Centargo (A CT injector) and Stellant Flex (MRI injector) and ordered supplies.
I participated in Human Factors Validation Testing for two devices: Net-Gen CT (CT injector): initial phase testing,
and Centargo (CT injector): Later, Phase testing following the FDA for product sales in the US.
Trained on RQM, ISO: 13485:2016, and FDA classification of devices and specific Project Management skills.
Assisted with the supply chain during COVID-19, visited the plant site in Indianola, and assisted with injectable
manufacturing on a sterile environment assembly line and developed a new idea for process optimization.