Mingh L.
Distinguished Engineer @ Genentech
About
Highly technical and versatile professional with more than (30) years in GMP manufacturing and with demonstrated success in project management, financial analysis, risk/failure assessment, qualification/validation, filling, labeling, cartoning, and case packing machines, incl. vision inspection systems, serialization, track & trace technologies.
United States
Hillsboro
Biotechnology
Pharmaceutical Industry, FDA, GMP, Validation, Change Control, Project Management, Cross-functional Team Leadership, Manufacturing, Packaging Machinery, Serialization, Machine Vision, Barcode, VBA
Experience

Senior Engineer
Hillsboro, Oregon, United States
Led site implementation for U.S. Drug Supply Chain Security Act ("Track & Trace"), accountable for scope, schedule, and budget to integrate Laetus Secure Track & Trace Solution (S-TTS) and vision components into new printing and case packing machines and to update Manufacturing Execution System (MES) to serialize cartons and aggregate to cases and pallets in accordance with Roche’s Supply Chain Control program. Served as point of contact to internal and external resources as well as provided startup support for (2) packaging lines.

Senior Engineer
Abbott Park, IL
• Led implementation of (2) packaging lines consisting of automated filling/capping machine, semi-automatic filling machine, semi-automatic capping and labeling machine by identifying strategies, technologies, requirements; managing budget, resources (suppliers and internal personnel), risks and schedule to support consolidation program. Implemented online stratified-random sampling of release torque in-process controls to enable application-to-release torque correlation. • Designed, coded and validated Visual Basic (VB) label printing software components and software application to enforce business requirements such as double blind data entry and reporting. Collaborated with regulatory labeling organization and IT organization to developed associated change control process. • Implemented Activplant’s Throughput Analyzer™ on device assembly machine and liquid filling lines to provide real-time manufacturing performance metrics including throughput, constraints and OEE. Recipient of Diagnostics Division Engineering Excellence Award.
Mingh L.'s Contact Information
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