Sterilization Engineer

About the Company

Tianyi Medical (Thailand) is a subsidiary of Tianyi Medical, a manufacturer of Class III medical consumables with over 30 years' experience. The company operates under an ISO 13485 certified Quality Management System and produces devices compliant with international regulatory requirements (NMPA, CE, FDA). Product portfolio includes blood purification consumables, infusion and nutrition devices, rehabilitation products and other medical consumables for global markets.

Responsibilities

• Lead sterilization process R&D activities, including design, development, changes, validation and revalidation for Ethylene Oxide (EO) and Radiation sterilization processes.
• Evaluate change controls and deviations related to EO and radiation sterilization processes.
• Provide technical support and collaborate with regulatory authorities and customers during audits, inspections and sterilization-related communications.
• Support maintenance and continuous improvement of CAPA activities and related quality system documentation.
• Manage process validation projects: planning, execution, monitoring and reporting of validation activities.
• Oversee validation activities to ensure completion according to approved plans and applicable validation standards.
• Coordinate with cross-functional teams (Production, R&D, QC, QA) and external parties (suppliers, relevant organizations) to meet validation requirements.
• Provide technical guidance and recommendations to project teams and senior management on process improvement and validation strategies.
• Perform other duties as assigned by supervisor.

Qualifications

• Age 25-40.
• Minimum 3 years of experience in sterilization processes or sterilization validation.
• Familiar with sterilization standards and guidelines, including ISO 11135, ISO 11137 and TIR 28.
• Comprehensive knowledge of sterilization principles and techniques; able to independently perform sterilization validation and prepare validation protocols, reports, SOPs and related documentation.
• Familiar with ISO 13485 Quality Management System and experienced in supporting internal and external audits.
• Strong communication and coordination skills.
• Strong problem-solving, analytical skills, learning agility and adaptability.
• Risk management capability and strong execution/project management skills.
• Ability to provide recommendations to project teams and senior management regarding process improvement and validation strategies.