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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.
Fully responsible for equipment installation, start-up, sustain, troubleshooting, and continuous improvement.
Directly involve in new equipment design, user requirement specification (URS), procurement, fabrication (include delivery management) installation, and qualification.
Prepare and maintain documentation, procedure, control plan, risk analysis, troubleshooting SOP and guideline accordingly to ISO13485 standard.
Provide guidance, training and coaching to technicians on machine monitoring, maintenance, troubleshooting and improvement projects.
Responsible for machine up time and readiness for production.
Liaise with manufacturing department and ensure scheduled preventive maintenance and periodic validations are performed within the set time frame.
Ensure adequate spare part inventory to support production and prepare monthly spare part purchase plan.
Involves in engineering projects such as cost reduction, OEE improvement, second source qualification, and yield improvement.
Review equipment data logs, error histories, and SPC charts to ensure equipment is operating within control limits.
Ensure 5S, Good Manufacturing Practices (GMP) and safety & health protocols compliances.
Other tasks assign by superior time to time.
Education level: Degree in Engineering or Diploma holder with minimum 5 years working experience. Preferably Mechanical/Mechatronic, Electrical & Electronics, Chemical Engineering.
Year of Experience: Preferable min 2-3 years related experience in machines handling and maintenance. Experience working in cleanroom environment will be added advantage.
Capability: Familiar with chemical process/ packaging process.
Skills: Knowledge in troubleshooting, PLC, 8D problem solving, FMEA, DMAIC.
Language: English and Bahasa Malaysia are must, Japanese will be an added advantage.