NQ- Global Process Senior Engineer / Lead

Role Summary: The Process Engineer on the Tech Transfer team is responsible for transferring, optimizing, and establishing stable and capable manufacturing processes at the overseas factory to produce products according to design specifications and quality standards. Key Responsibilities: 1. Process Understanding & Transfer: -Thoroughly understand the manufacturing processes, equipment, and critical process parameters from the sending site. -Oversee the installation, setup, and commissioning of new or transferred manufacturing equipment. -Develop and standardize detailed process flows, work instructions, and Standard Operating Procedures (SOPs). 2. Process Validation & Optimization: -Lead or participate in IQ/OQ/PQ activities for manufacturing processes and equipment. - Conduct Process Capability (Cp/Cpk) studies to ensure the transferred process can consistently meet product specifications. - Identify process bottlenecks and areas for improvement; implement process optimizations during pilot and early production phases. 3. Problem Solving & Root Cause Analysis: - Collaborate with QA and Test Engineers to troubleshoot production issues, yield deviations, and quality defects. - Apply problem-solving methodologies (e.g., 8D, Fishbone, 5 Whys) to identify and eliminate root causes of process-related issues. 4. Training & Support: - Provide technical training and guidance to production operators, supervisors, and maintenance personnel on new processes and equipment. - Act as the primary technical contact for process-related inquiries during the TT phase. 5. Documentation: - Create and maintain all process-related documentation, including PFMEA, Control Plans, work instructions, and process flow diagrams.