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.