Process Equipment Senior Engineer

Key Responsibilities: · Acquire a strong understanding of production processes, and integrate process knowledge with equipment technology to support manufacturing excellence. · Provide technical training and knowledge transfer on production process to other PE team members, contributing to overall team capability enhancement. · Act as a technical interface with customers, supporting equipment and process-related discussions, issue analysis, and solution implementation. · Learn, adopt, and apply best-in-class equipment management methodologies (e.g. reliability engineering, preventive and predictive maintenance). · Troubleshoot technical issues during equipment operation, optimize efficiency of production lines, and reduce failure rates. · Document root cause analysis and lessons learned for equipment-related problems. · Develop and optimize preventive maintenance and predictive maintenance plans to ensure equipment reliability. · Prioritize spare parts classification and establish rational inventory levels for critical components. · Collaborate with production and quality departments to ensure equipment meets process requirements and relevant regulatory standards. · Continuously identify and eliminate potential audit risks to achieve audit readiness as a routine practice. · Provide technical support during internal audits, FDA/EMA/HSA inspections, and client audits. · Lead or support deviation investigations, CAPA development, change control, periodic reviews, and risk assessments (HAZOP, FMEA, CMMS updates). · Ensure timely and accurate updates of system documentation (SOPs, Maximo job plans, equipment files). · Other tasks assigned by superior. REQUIREMENTS: · Good communication, and cross-functional coordination skills. · Language: proficiency in English (written and spoken), speak Mandarin is an advantage. · Bachelor or above degree in Biomedical Engineering, or Pharmaceutical related, or Electrical / Automation / Mechanical engineering related.