PRODUCTION OPERATOR

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

Operate, maintain, and troubleshoot process equipment utilized in the cleanroom label and sterile disinfectant business, and be able to make minor equipment adjustments as needed.

Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.

Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.

Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.

Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.

Enter and record production activities in production log sheet systems for specific work orders.

Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 9001 & ISO13485requirements.

Responsible for reporting all discrepancies to the Supervisor or Production Manager.

Support department and plant Safety goals by continuously demonstrating safe behaviour.

Maintain a clean and orderly work area.

Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements

Perform other manufacturing activities as assigned by the department leadership

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

High School diploma or equivalent.

0 – 2 years of chemical processing experience or batch mixing in Medical Device or Pharmaceutical manufacturing industry. Production experience is highly desirable.

Basic computer skills for email and data entry.

Must read, write and speak in English & Bahasa Melayu, and communicate clearly and concisely.

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.

Ability to gown to ISO Class 5 and 7 Clean Room standards.

Able to work overtime

PHYSICAL REQUIREMENTS

The employee must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.

Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.

Ability to gown to ISO Class 5 Clean Room standards and/or additional Clean room clothing

Ability to gown to ISO Class 7 Clean Room standards and/or additional Clean room clothing

Ability to stand for 8 hours

Must be able to climb step ladders, without assistance

Vision: Requires eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of the quality reclassification.