Sterilization Engineer

About Tianyi Medical (Thailand)

Tianyi Medical (Thailand) is a subsidiary of Tianyi Medical, a leading manufacturer of Class III medical consumables with over 30 years of experience in the medical device industry. Headquartered in China, Tianyi Medical specializes in the research, development, manufacturing, and distribution of high-quality medical devices and consumables for global healthcare markets.

The company operates under an ISO 13485 certified Quality Management System, and its products comply with international regulatory requirements, including NMPA, CE, FDA, and other applicable certifications. Tianyi Medical serves customers across Asia, Europe, North America, and South America.

Our product portfolio includes blood purification consumables, infusion and nutrition devices, rehabilitation products, and other medical consumables designed to support healthcare professionals and improve patient outcomes worldwide.

As our business continues to grow, we are looking for talented and passionate professionals to join our team and contribute to the development of innovative, high-quality medical solutions for the global healthcare industry.

Job Description

1. Responsible for sterilization process research and development activities, including process design, development, changes, validation, revalidation, and other related sterilization activities for Ethylene Oxide (EO) and Radiation Sterilization processes.
2. Responsible for evaluating change controls and deviations related to EO sterilization processes.
3. Responsible for evaluating change controls and deviations related to radiation sterilization processes.
4. Provide technical support and collaborate with regulatory authorities and customers during audits, inspections, and sterilization-related communications.
5. Support the maintenance and continuous improvement of CAPA activities and related quality system documentation.
6. Manage process validation projects, including planning, execution, monitoring, and reporting of validation activities.
7. Oversee validation processes to ensure all activities are completed according to approved plans and applicable validation standards.
8. Coordinate with cross-functional teams, including Production, Research & Development (R&D), Quality Control (QC), and Quality Assurance (QA), to ensure the effectiveness and compliance of validation activities.
9. Coordinate with external parties, such as suppliers and relevant organizations, to ensure validation requirements and conditions are met.
10. Provide technical guidance and recommendations to project teams and senior management regarding process improvement and validation strategies.
11. Perform other duties as assigned by the supervisor.

Qualifications

1. 25-40
2. Minimum 3 years of experience in sterilization processes or sterilization validation.
3. Familiar with sterilization standards and guidelines, including ISO 11135, ISO 11137, and TIR 28.
4. Possess comprehensive knowledge of sterilization principles and techniques, with the ability to independently perform sterilization validation, prepare validation protocols, reports, SOPs, and related documentation.
5. Familiar with ISO 13485 Quality Management System and experienced in supporting internal and external audits.
6. Strong communication and coordination skills.
7. Strong problem-solving skills.
8. Good learning agility and adaptability.
9. Risk management capability.
10. Strong analytical skills.
11. Strong execution and project management skills.
12. Ability to provide recommendations to project teams and senior management on process improvement and validation strategies.