Facility Engineer – Medical Device Cleanroom & Compliance

Epsilon Medical Devices Sdn Bhd; Kamunting; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Performance-based bonuses

Career development opportunities

Job summary

Epsilon Medical Devices Sdn Bhd in Kamunting Perak seeks a Facility Engineer to ensure reliable operation of our manufacturing facility. You will develop preventive maintenance, monitor cleanroom environments, and support equipment commissioning and calibration to meet ISO 14644, GMP, and ISO 13485 standards.

The ideal candidate has at least 5 years in equipment management, hands-on installation and revalidation, strong problem-solving and documentation skills, and the ability to collaborate

Qualifications

• Degree in Mechanical, Electrical, Automation, or related fields.
• At least 5 years of relevant experience in equipment management, with practical experience in equipment installation and commissioning.
• Familiar with cleanroom HVAC systems, dust-free equipment, and ESD control technologies.
• Understand the requirements of ISO, GMP, FDA, and other clean-environment regulations.
• Possess data-driven problem analysis and resolution abilities. Have a continuous improvement mindset and project management experience.
• Excellent communication and coordination skills, a strong team spirit, and strong documentation-writing skills.

Responsibilities

• Develop and implement preventive maintenance plans for equipment.
• Respond quickly to equipment failures and perform root cause analysis.
• Monitor clean room environmental parameters to ensure ISO 14644 and GMP compliance.
• Maintain HVAC systems, FFUs, water/gas systems, and ESD protection in clean rooms.
• Propose equipment tech transformation solutions and lead revalidation efforts.
• Manage calibration/verification of measuring instruments and metrology data.
• Provide technical support to production and reduce downtime.
• Ensure safety compliance with ISO 13485 and FDA, organize emergency drills.
• Collaborate with production, quality, supply chain to resolve issues.
• Maintain logs and submit reports and improvement proposals.

Skills

Data-driven analysis

Problem solving

Project management

Documentation writing

Communication

Education

Bachelor's degree in Mechanical, Electrical, Automation, or related fields

Job description

Epsilon Medical Devices Sdn Bhd in Kamunting Perak seeks a Facility Engineer to ensure reliable operation of our manufacturing facility. You will develop preventive maintenance, monitor cleanroom environments, and support equipment commissioning and calibration to meet ISO 14644, GMP, and ISO 13485 standards.

The ideal candidate has at least 5 years in equipment management, hands-on installation and revalidation, strong problem-solving and documentation skills, and the ability to collaborate