Facility / Equipment Engineer

• Establish and execute preventive maintenance programs, conduct routine inspections, perform condition monitoring and troubleshooting to ensure equipment operates at optimal efficiency and achieves OEE targets.
  
• Provide prompt response to equipment breakdowns, carry out root cause analysis, implement corrective improvements, manage spare parts inventory, and optimize procurement lead time and cost efficiency.
  
• Oversee cleanroom environmental conditions, including temperature, humidity, pressure differentials, and particle counts, to ensure compliance with ISO 14644, GMP, and other applicable standards.
  
• Maintain critical cleanroom systems such as HVAC, FFUs, purified water and high -purity gas systems, and ESD protection equipment, while planning and executing periodic cleaning, disinfection, and certification activities.
  
• Recommend and implement technical upgrades for equipment; participate in equipment selection, installation, commissioning, and acceptance processes; and lead revalidation activities as required.
  
• Oversee routine calibration and verification of measuring instruments, develop and maintain the metrology management system, and leverage data analysis to drive continuous improvement.
  
• Deliver technical support to production operations, troubleshoot unexpected issues, assist with process parameter adjustments, and minimize equipment downtime.
  
• Enforce equipment safety controls, identify and mitigate potential hazards, ensure regulatory compliance with standards such as ISO 13485 and FDA requirements, and organize emergency preparedness drills.
  
• Work closely with production, quality, supply chain, and other departments to address equipment -related challenges, and support equipment suitability assessments and cleanroom validation during new product introduction.
  
• Maintain comprehensive equipment documentation, including asset registers, maintenance records, calibration reports, and environmental monitoring data, and provide regular operational, failure analysis, and improvement reports.
  

Requirements

• Bachelor’s degree or above in Mechanical Engineering, Electrical Engineering, Automation, or a related discipline.
  
• Minimum of 5 years’ experience in equipment management, with hands -on involvement in equipment installation and commissioning.
  
• Familiar with cleanroom HVAC systems, contamination -controlled equipment, and ESD protection technologies, with strong capability in equipment troubleshooting and repair.
  
• Knowledgeable in ISO, GMP, FDA, and other clean -environment regulatory requirements, with a strong focus on compliance and regulatory adherence.
  
• Demonstrates strong data -driven analytical and problem -solving skills, with a continuous improvement mindset and experience in managing improvement or technical projects.
  
• Excellent communication and coordination abilities, strong team orientation, and solid technical documentation skills.