Cleanroom Production Operator with GMP/ISO

PMA Manufacturing Sdn Bhd; George Town; On-site; MYR 24,000 - 36,000; Full time

Job summary

PMA Manufacturing Sdn Bhd in Penang seeks a capable operator to operate, maintain and troubleshoot process equipment in our cleanroom label and sterile disinfectant lines. You will perform precise measurements, record data, and follow GMP and ISO procedures.

The role requires gowning to ISO Class 5/7 and the ability to work shifts, overtime, and coordinate with QA/QC to ensure batch milestones are met while maintaining a safe, orderly work area and accurate logs.

Qualifications

• High School diploma or equivalent.
• 0–2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing.
• Basic computer skills for email and data entry.
• Must read, write and speak in English & Bahasa Melayu, and communicate clearly.
• Fundamental understanding of mathematics and chemistry.
• Able to participate in a team-oriented environment, willingness to assist and train others.
• Able to work independently with minimal supervision.
• Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
• Able to gown to ISO Class 5 and 7 Clean Room standards.
• Able to work overtime.

Responsibilities

• Operate, maintain, and troubleshoot process equipment in the cleanroom label and sterile disinfectant lines.
• Take precise measurements and use measurement equipment to accurately add chemicals to batches.
• Maintain gowning qualification for ISO Class 5/7 cleanroom operations.
• Keep legible records and comply with GMP, ISO 9001 & ISO13485, SOPs, and safety requirements.
• Coordinate with QA/QC/Materials to inspect subassemblies and finished products.
• Log production activities in production systems for specific work orders.
• Follow SOPs and regulatory requirements; report discrepancies to supervisors.
• Support safety goals and maintain a clean, orderly work area.
• Work flexible shifts and days to meet batch milestones.
• Perform other manufacturing activities as assigned by leadership.

Skills

Process equipment operation

Gowning ISO 5/7

Documentation and data entry

QA/QC liaison

English & Bahasa Melayu communication

Education

High School diploma or equivalent

Tools

Measurement equipment

Calibration tools

Job description

PMA Manufacturing Sdn Bhd in Penang seeks a capable operator to operate, maintain and troubleshoot process equipment in our cleanroom label and sterile disinfectant lines. You will perform precise measurements, record data, and follow GMP and ISO procedures.

The role requires gowning to ISO Class 5/7 and the ability to work shifts, overtime, and coordinate with QA/QC to ensure batch milestones are met while maintaining a safe, orderly work area and accurate logs.