About the Role

This position ensures the microbiological and chemical quality of medical devices by performing essential laboratory tests (bioburden, EO residuals, particulate contamination...), maintaining biological laboratory equipment, and supporting SOP documentation and training in alignment with ISO and internal quality standards.

Key Responsibilities

1. Ethylene Oxide (EO) Residual Testing

• Develop testing plans and perform method validation using Gas Chromatography.
• Prepare required chemicals, tools, and test materials.
• Conduct tests and prepare corresponding reports.
• Escalate abnormalities or issues to the Team Leader.

2. Bioburden Testing for Semi‑Finished Goods

• Prepare tools and testing materials.
• Execute bioburden tests and report results.
• Communicate results to relevant departments.
• Perform Laboratory OOS investigations when abnormal results occur.
• Weekly update sampling plan in alignment with planning team.

3. Particulate Contamination Testing

• Prepare testing tools and materials.
• Conduct testing and prepare reports.
• Perform OOS investigations when required.

4. Equipment Calibration & Maintenance Monitoring

• Coordinate registration, modification, or removal of equipment for calibration and maintenance.
• Support relevant departments during calibration/maintenance processes.
• Monitor calibration due dates to ensure compliance.
• Weekly download and review incubator temperature data, reporting abnormalities.
• Collaborate with RCR team or vendors for troubleshooting when equipment issues arise.

5. SOP & Documentation Management

• Create, revise, and update SOPs, technical sheets, and work instructions.
• Conduct training and evaluation for team members.
• Review current documents (TM/TS) to identify opportunities for improvement.

6. Other Assigned Tasks

• Participate in CSV projects.
• Propose and implement kaizen/improvement ideas upon approval.
• Perform additional tasks assigned by superiors.

Authorization

• Arrange routine testing tasks following supervisor assignments.
• Propose overtime when necessary to meet testing and validation deadlines.
• Submit improvement proposals and execute approved kaizen initiatives.

Internal & External Working Relations

Internal

• QC Executive: Process/SOP improvements and approvals
• Production Team: Validation plans, change control, testing requests
• Q&V Team: Process validation requirements, CSV topics

External

• Vendors & Suppliers: Equipment installation and technical issue resolution
• External Laboratories: Coordination for outsourced testing
• National Institute: Participation in microbiology training courses

Qualifications

Education

Must have:

• Degree in Chemistry

Nice to have:

• Bachelor’s or Engineering Degree
• Lean Six Sigma certification

Experience

Must have:

• At least 3 years of experience in Chemistry
• Good understanding of production processes

Nice to have:

• Experience in Bioburden testing
• Experience with Gas Chromatography

Skills

• English communication
• Strong Vietnamese (native language) communication
• Proficiency in MS Word & Excel
• Logical thinking and analytical mindset
• Teamwork and collaboration skills