Brownsburg, Indiana, United States
Experienced CQV/Project Engineer with a history working in the medical device industry. Skilled in Biological Engineering, Packaging Development, Equipment Qualification, Microsoft Word, and Product Development. Strong engineering professional with a Bachelor's Degree focused in Biological Engineering from Purdue University.
I worked as a CQV project engineer for combination products and packaging development in the medical device industry. I performed design control and risk management activities for the development of medical devices and packaging. I have worked on line and equipment installation in pharmaceutical processing and packaging. I created and execute test documents to qualify the equipment and facilities according to plant and FDA standards.
As a Student Assistant, I provided aid to the staff in the Office of Academic Programs such as greeting and guiding guests and visitors, answering questions and giving information, creating and editing documents, handling sensitive information, and completing regular projects for academic programs.
Working in the Life Science Polymers department, I performed research in Advanced Materials lab testing thickening agents, emulsifiers, and pharmaceuticals, tested material properties of thickening agents, emulsifiers, and pharmaceuticals; such as viscosity, pH, and hardness; using a rheometer, pH meter, mixer, and durometer; and kept a lab notebook for records, and I researched existing patents to discover innovative opportunities for existing products. I also created an informational handout to educate customers about product sterilization and hazards for medical plastics. I completed regulatory work by updating Drug Master Files for multiple pharmaceutical products that had been amended and filing annual updates with the FDA. I compiled market data from various catalogs and international trade records as a basis for expansion of medical device and pharmaceutical sales. I benchmarked competitors based on marketing and financial reports of plastic products and related additives.