Process Equipment 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.