Fullerton, California, United States
● Perform validation consulting services, including process validation and equipment qualification, protocol generation and execution, data analysis and reporting, and calibration ● Communicate with customers to develop validation documentation, schedule projects and communicate study results ● Analyze and interpret data from qualification studies and determine if it meets acceptance criteria ● Worked on Operation Warp Speed to prepare equipment to produce covid-19 vaccine ● Perform software qualifications on Ellab’s environmental monitoring software Valsuite
Led commissioning and qualification of an entire API drug facility, ensuring regulatory audit approval. Provided process validation and equipment commissioning and qualification consulting, including protocol writing, execution, data analysis, and reporting.
• Prepare chemical solutions and experiments for undergraduate students • Fix chemical testing equipment • Assist students with laboratory equipment