Engineer Ii, Drug Product Process Engineering (Formerly Manufacturing Science And Technology)
South San Francisco, California, Us
Starting Jan 2017:- Officially transferred to the Project and Equipment group in September 2017.- As of June 2017, interim project manager and process engineer for the implementation of controlled ice nucleation lyophilization technology in the commercial manufacturing facility. Responsible for project leadership, execution logistics, deliverables, schedule, budget, co-authoring protocols, and communication to upper management. Also acted as single point of contact for multiple engineering runs responsible for oversight, logistics, scheduling, and troubleshooting.- Site technical representative for Drug Product single use technologies across Roche single-use network.- Responsible for single-use technology at South San Francisco Drug Product manufacturing facilities, including implementation of single-use technologies.- Responsible for implementation of single-use assemblies and other raw materials for new Roche network standard modular fill line (Vanrx SA25).- Lead for implementation of automated fill checkweighing system.From August 2015 until Jan 2017:- Responsible for 24/7 technical support of commercial and clinical drug product operations including tactical, project, and process support. - Lead and support equipment and process troubleshooting. - Implement engineering projects to improve success rates, reduce recurring discrepancies, and increase capacity/productivity. - Support investigations as technical SME. - Author robust technical assessments for discrepant events. - Manage group's troubleshooting lab, including qualification of equipment and expansion of capabilities.