Equipment Engineer - Cleanroom & GMP Uptime Specialist

MENICON MALAYSIA SDN. BHD.; Kedah; On-site; MYR 60,000 - 100,000; Full time

Job summary

MENICON MALAYSIA SDN. BHD. in Kedah seeks an experienced equipment engineer to lead installation, start-up, sustainment, troubleshooting and continuous improvement across manufacturing lines.

You will prepare ISO13485 documentation, train technicians, ensure GMP and safety compliance, manage spare parts and drive cost and yield improvements. Proficiency in English and Bahasa Malaysia is required; Japanese is a plus.

Qualifications

• Degree in Engineering or Diploma with min 5 years in machines handling and maintenance.
• Experience in cleanroom environment is an added advantage.
• English and Bahasa Malaysia are must; Japanese will be an added advantage.
• Preferably Mechanical/Mechatronic, Electrical & Electronics, Chemical Engineering.

Responsibilities

• Install and commission new equipment, including start-up and qualification.
• Troubleshoot and sustain machine performance with continuous improvement.
• Prepare and maintain ISO13485 compliant documentation, SOPs and risk analyses.
• Provide guidance and training to technicians on maintenance and monitoring.
• Ensure machine uptime and readiness for production.
• Coordinate preventive maintenance and scheduled validations.
• Manage spare parts inventory and monthly purchase planning.
• Engage in cost reduction, OEE, yield improvement and validation activities.
• Review equipment data logs and SPC charts to ensure operation within limits.
• Ensure 5S, GMP and safety health protocol compliance.
• Carry out other tasks as assigned.

Skills

PLC

8D problem solving

FMEA

DMAIC

Troubleshooting

Education

Bachelor or Diploma in Engineering

Job description

MENICON MALAYSIA SDN. BHD. in Kedah seeks an experienced equipment engineer to lead installation, start-up, sustainment, troubleshooting and continuous improvement across manufacturing lines.

You will prepare ISO13485 documentation, train technicians, ensure GMP and safety compliance, manage spare parts and drive cost and yield improvements. Proficiency in English and Bahasa Malaysia is required; Japanese is a plus.