Facility Engineer

Epsilon Medical Devices Sdn Bhd; Kamunting; Vor Ort; MYR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Performance-based bonuses

Career development opportunities

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Data-driven analysis

Problem solving

Project management

Documentation writing

Communication

Ausbildung

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

Jobbeschreibung

About the role

Epsilon Medical Devices Sdn Bhd is seeking a talented Facility Engineer to join our team in Kamunting Perak. As a Facility Engineer, you will play a crucial role in ensuring the efficient and reliable operation of our manufacturing facility. This full-time position offers an exciting opportunity to apply your expertise in engineering to support the strategic objectives of our growing medical devices company.

What you'll be doing

Develop and implement preventive maintenance plans for equipment, conduct daily inspections, condition monitoring, and fault diagnosis to ensure overall equipment effectiveness (OEE) meets targets;

Respond quickly to equipment failures, perform root cause analysis, drive improvement measures, manage spare parts inventory, and optimize procurement cycles and costs;

Monitor clean room environmental parameters (temperature, humidity, pressure differential, particle counts, etc.) to ensure compliance with ISO 14644, GMP, and other relevant standards;

Maintain key cleanroom facilities such as HVAC systems, FFUs, pure water/high-purity gas systems, and ESD protection equipment. Develop and execute regular cleanroom cleaning, disinfection, and certification plans;

Propose equipment technical transformation solutions, participate in new equipment selection, installation, commissioning, and acceptance. Lead equipment revalidation efforts;

Manage the regular calibration and verification of measuring instruments, establish and maintain a metrology management system, and utilize data for continuous improvement;

Provide technical support to the production department, resolve unexpected technical issues, participate in process parameter debugging, and reduce downtime.

Implement equipment safety protection measures, identify potential safety hazards, and ensure equipment operations comply with regulations such as ISO 13485 and FDA. Develop and organize emergency response drills;

Collaborate with production, quality, supply chain, and other departments to resolve equipment-related issues. Support equipment adaptability assessments and clean environment validation during new product introduction phases;

Maintain equipment logs, repair records, calibration reports, and cleanroom environmental monitoring data. Regularly submit equipment operation reports, failure analysis reports, and improvement proposals.

What we're looking for

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. Proficient in equipment failure analysis and repair methods;

Understand the requirements of ISO, GMP, FDA, and other clean-environment regulations. Possess a strong compliance mindset;

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.

What we offer

Competitive salary and performance-based bonuses

Opportunities for continuous learning and career advancement

Company Information

We are an established ISO 9001 and ISO 13485 Certified Medical Device Manufacturing Company. We specialise in manufacture and assembly of plastic injection molded and extruded components for medical applications.

We are an established ISO 9001 and ISO 13485 Certified Medical Device Manufacturing Company. We specialise in manufacture and assembly of plastic injection molded and extruded components for medical applications.