Staff Bioautomation Engineer
Pleasanton, California, United States
Key developer in setting up a COVID lab to automate the tubing process to produce over 10M kits a week with all equipment ordered, delivered, developed, tested and implemented in production in a 2-week period.• Serves as the core team member for New Product Introduction (NPI), responsible for requirements gathering, system interaction, process design and development, and testing validation activities.• Sets up Pleasanton GMP lab from scratch, developing robotics methods/processes and overall manufacturing processes, qualifying equipment and documenting procedures and results for FDA audits and submission to commercialization of multiple RUO and IVD products.• Demonstrates strong leadership capability by coaching junior members and new hires, works with overseas colleagues to develop robotics methods/processes, setting up multiple international manufacturing labs and successfully transferring product lines to the UK, China and Singapore sites.• Leads the BioAutomation group when the manager is not available, ensures the deliverables and projects are on track. Provides solutions and business knowledge to the project and management team, collaborates with cross functional groups, such as IT, Pilot, Verification &Validation, Project and Product management and Manufacturing from development to product commercialization.• Initiates touch-point-agreement (TPA) document with IT group for the successful infrastructure setup and integration between robotics instruments and new MES. Utilizes proficiency in Oracle SQL developer tool in managing database tables.• Defines and designs best fit processes based on product, development, and manufacturing requirements. Point-contact for Pleasanton site on Robotics in-process spec setup and formulation of new products.• Acts as SME for robotics area in full cycle end-to-end development of new product introduction from POC (prove of concept) to design, development to testing and implementation in production.