LAB ENGINEER (Aseptic)

To perform testing, validation, and support activities for aseptic filling, sealing, and capping equipment in a controlled lab environment. The Lab Engineer ensures all tests are conducted in compliance with GMP, ISO, and cleanroom standards, providing critical data to optimize machine performance for sterile applications.

Main Tasks

• Set up and perform tests on aseptic filling machines, isolators, and capping systems using customer-supplied or simulated sterile products and containers.
• Evaluate filling accuracy, nozzle compatibility, capping torque, and sealing integrity in sterile or clean conditions.
• Analyze product characteristics (viscosity, density, foam generation) and assess their impact on machine performance.
• Perform test runs with simulated cleanroom protocols to assess compatibility with isolator or RABS systems.
• Conduct compatibility checks between the machine design and customer packaging (e.g., vials, bottles, stoppers, caps).
• Record all test data and observations in formal lab reports, including conclusions and recommendations for machine configuration.
• Assist in factory acceptance tests (FAT) preparation by validating test protocols and machine readiness.
• Collaborate with automation to troubleshoot test results or suggest improvements.
• Ensure all lab activities follow GMP and cleanroom operational standards.
• Maintain lab cleanliness, material handling compliance, and proper disposal of test substances or biological simulants.

Information Technology

Competences & Qualifications

Serac Asia Sdn Bhd is a manufacturer of blowing, filling and capping machines in Malaysia and has been in the country since 1994. For more information please visit our website

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