I work within the Engineering group to ensure the company's equipment perform according to quality standards and that manufacturing processes are capable and qualified. I was able to qualify different types of equipment such as autoclaves, incubators, and dry heat ovens. I am familiar with using wireless and wired thermocouples (Kayes, Lives International, etc.) Currently, our company is undergoing multiple CAPEX projects, which gave me the opportunity to work with different interdisciplinary teams, such as QA, QC, Production, and Regulatory. I was able to work on some projects that involved with 21 CFR Part 11 guidelines. Not only was I was able to author and execute IQOQPQ protocols, I created new Standard Operating Procedures, which were able to improve the validation process throughout the production area without interrupting the manufacturing process. I was involved with number of deviation cases, so I am familiar with root cause analysis as well as other investigation methods.