Clean & Pack Engineer

Straits Orthopaedics (Mfg) Sdn Bhd; Seberang Perai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical device manufacturer in Malaysia is looking for a qualified individual to oversee the cleaning processes and ensure compliance with applicable standards. The ideal candidate will hold a degree in biology, microbiology, chemistry, or chemical engineering, and have a minimum of 3 years of experience in the medical device or pharmaceutical fields. Responsibilities include monitoring cleaning machines, conducting audits, and training personnel. Familiarity with ISO standards is preferred.

Qualifications

• Minimum 3 years of related experience in medical device or pharmaceutical product manufacturing.
• Familiarity with cleanroom operation and environment maintenance.
• Training on ISO13485, ISO9001, and regulatory requirements.

Responsibilities

• Monitor, analyse and maintain cleaning machines parameters’ health.
• Conduct periodic process audits and prepare work instructions.
• Evaluate and control consumption of cleaning detergents and chemicals.
• Participate in compliance audits and train personnel on contamination control.

Skills

Manufacturing process validation

Microbial contamination sampling

Risk assessment

Systematic root cause analysis

Education

Degree in biology, microbiology, chemistry, or chemical engineering

Job description

Key Responsibilities

• Monitor, analyse and maintain cleaning machines parameters’ health.
• Monitor and evaluate the impact of production activities and material handling methods.
• Perform periodic process audit.
• Prepare and implement work instructions.
• Establish and improve the process control methods.
• Evaluate and analyse the risk of change in the Final Clean.
• Evaluate, monitor and control consumption of cleaning detergent and chemicals.
• Review and implement applicable standards.
• Manage out-of-control controlled conditions, troubleshoot with PM team and supplier to recover the controlled condition ASAP, evaluate and determine the disposition of the affected products, report the incident.

Water Quality Controls

• Perform DI water sampling.
• Liaise with lab test service provider on the lab test.
• Review lab test report and determine necessary actions.
• Trend and analyse lab test data and determine necessary preventive action.
• Monitor the water quality of the cleaning processes.
• Review and implement applicable standards on contamination controls.
• Manage out-of-control controlled conditions, work with Engineering to recover the controlled condition ASAP, evaluate and determine the disposition of the affected products, report the incident.

Process & Software Validation

• Understand customers’ requirements on the process control and process validation.
• Lead and execute the approved validation protocol.
• Establish the process validation report.
• Initiate and execute necessary change based on the process & software validation output.
• Resolve issues in the process & software validation.
• Liaise with the customers on the process validation.
• Participate in the investigation of process and product nonconformities.
• Perform / arrange for required test, determine, and implement necessary actions.

Audit

• Participate in the compliance audits.

Conduct Training

• Train personnel on contamination control.
• Train Personnel on work instructions.
• Train personnel on the do and don’t in the cleanroom.

Job Requirements

Degree in biology, microbiology, chemistry, or chemical engineering.

Preferably 3 years related experience in the medical device or pharmaceutical product manufacturing, product cleaning and packaging, cleanroom operation and environment maintenance and/or manufacturing process validation.

Preferably trained on ISO13485, ISO9001, medical device related regulatory requirements and risk management.

Preferably attained the skill of manufacturing process validation, microbial contamination sampling, systematic root cause analysis and problem solving, and risk assessment.

Able to work at Teluk Kumbar and Batu Kawan by Q4 2025.