Clean Room Engineer / Leak Test

Frencken; Bandar Baru Bangi; On-site; MYR 60,000 - 90,000; Full time

Job summary

Frencken seeks a qualified Clean Room Engineer / Leak Test to join our team in Malaysia. You will design, operate, monitor, and optimize cleanroom facilities and systems to meet regulatory and quality standards.

You will collaborate with Quality Assurance, Validation, Facilities, and Manufacturing to maintain an efficient, compliant cleanroom, support qualification and maintenance, and drive continuous improvement.

Qualifications

• Bachelor's Degree in Engineering in relevant disciplines.
• 2–5 years of cleanroom manufacturing experience.
• Experience in regulated industries (semiconductor/pharma/biotech/medical devices) preferred.

Responsibilities

• Design, operate, monitor, and optimize cleanroom facilities and systems.
• Ensure cleanroom operations comply with quality, safety, and regulatory requirements.
• Develop and implement continuous improvement initiatives to enhance cleanroom performance and efficiency.
• Collaborate with Quality Assurance, Validation, Facilities, and Manufacturing to resolve operational issues and improve processes.
• Support cleanroom qualification, validation, monitoring, and maintenance activities.
• Analyze operational and environmental data to identify trends and improvement opportunities.
• Participate in audits, inspections, and corrective action activities related to cleanroom operations.
• Ensure proper documentation and adherence to established procedures and standards.

Skills

Lean Manufacturing

Six Sigma

Data analysis

Cross-functional teamwork

Process control systems

Analytical problem solving

Education

Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related disciplines)

Job description

Job Overview

We are seeking a qualified and motivated Clean Room Engineer / Leak Test to join our team. The successful candidate will be responsible for the design, operation, monitoring, and continuous improvement of cleanroom environments to ensure compliance with regulatory requirements and quality standards. This position works closely with cross-functional teams including Quality Assurance, Validation, Facilities, and Manufacturing to maintain an efficient and compliant cleanroom facility.

Key Responsibilities

• Design, operate, monitor, and optimize cleanroom facilities and systems.


• Ensure cleanroom operations comply with applicable quality, safety, and regulatory requirements.


• Develop and implement continuous improvement initiatives to enhance cleanroom performance and efficiency.


• Collaborate with Quality Assurance, Validation, Facilities, and Manufacturing teams to resolve operational issues and improve processes.


• Support cleanroom qualification, validation, monitoring, and maintenance activities.


• Analyze operational and environmental data to identify trends and improvement opportunities.


• Participate in audits, inspections, and corrective action activities related to cleanroom operations.


• Ensure proper documentation and adherence to established procedures and standards.

Requirements

Education

• Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related disciplines), or equivalent industry experience.

Experience

• Minimum 2-5 years of experience in cleanroom manufacturing environments.


• Experience within semiconductor, pharmaceutical, biotechnology, medical device, or similar regulated industries is preferred.

Knowledge, Skills & Abilities

• Certification in cleanroom operations (e.g., Certified Cleanroom Technician) is an added advantage.


• Experience in Lean Manufacturing, Continuous Improvement, or Six Sigma methodologies.


• Knowledge of process control systems and data analysis techniques.


• Strong analytical and problem-solving skills.


• Excellent communication and teamwork abilities.


• Ability to work effectively in a cross-functional manufacturing environment.


• Knowledge of cleanroom standards, contamination control practices, and regulatory requirements.