Sterilization Engineer

About the role

Tianyi Medical (Thailand) Co.,Ltd. is seeking a Sterilization Engineer to join our team on a full-time basis in ปลวกแดง, ระยอง. This is a strategic position that plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of our medical devices and equipment through advanced sterilisation processes. As a Sterilization Engineer, you will be instrumental in maintaining the highest standards of product quality and patient safety, whilst contributing directly to our company's reputation for excellence in the aerospace engineering and medical device sectors.

Key responsibilities

• Develop, validate and maintain sterilisation processes for medical devices and equipment in accordance with international standards and regulatory requirements
• Design and optimise sterilisation protocols using various methods including steam, ethylene oxide, radiation and other emerging sterilisation technologies
• Conduct sterilisation validation studies and generate comprehensive technical documentation to support regulatory submissions
• Monitor and analyse sterilisation equipment performance, ensuring all systems operate within specified parameters and compliance requirements
• Troubleshoot sterilisation process failures and implement corrective and preventative actions to address deficiencies
• Collaborate with quality assurance, manufacturing and regulatory teams to ensure compliance with ISO 11135, ISO 11137, ISO 14937 and other relevant sterilisation standards
• Perform risk assessments related to sterilisation processes and develop mitigation strategies
• Maintain detailed records of all sterilisation validation activities, process changes and equipment maintenance
• Train and support manufacturing personnel on proper sterilisation procedures and best practices
• Stay current with advances in sterilisation technology and recommend improvements to enhance process efficiency and product quality

What we're looking for

• Bachelor's degree in Engineering (preferably Chemical, Biomedical, or Mechanical Engineering) or equivalent professional qualification
• Minimum 3-5 years of professional experience in sterilisation engineering or related quality assurance roles within the medical device or pharmaceutical industry
• Demonstrated knowledge of sterilisation methods including steam, ethylene oxide, radiation and hydrogen peroxide gas plasma sterilisation
• Strong understanding of relevant international standards and regulations including ISO 11135, ISO 11137, FDA guidelines and ICH requirements
• Proficiency in process validation and statistical analysis methods
• Experience with sterilisation equipment operation, maintenance and troubleshooting
• Excellent problem-solving skills with the ability to identify root causes and implement effective solutions
• Strong written and verbal communication abilities in English; Thai language skills are advantageous
• Proficiency with quality management systems and documentation software
• Attention to detail and commitment to maintaining rigorous compliance standards
• Experience working in a regulated manufacturing environment
• Familiarity with aerospace engineering applications is considered a plus

What we offer

Tianyi Medical (Thailand) Co.,Ltd. is committed to supporting the professional development and wellbeing of our employees. We offer competitive compensation packages, opportunities for ongoing technical training and professional certifications, and a collaborative work environment that values innovation and continuous improvement. We provide a supportive workplace culture where your contributions are recognised and valued, and where you can develop your career in a dynamic and growing organisation. Our commitment to work-life balance and employee welfare ensures that you can perform at your best whilst maintaining personal wellbeing.

About us

Tianyi Medical (Thailand) Co.,Ltd. is a leading organisation in the medical device and aerospace engineering sectors, dedicated to delivering high-quality products that enhance patient safety and medical outcomes. With our expertise in precision engineering and commitment to stringent quality standards, we serve healthcare providers and organisations across the region. Our mission is to advance medical technology through rigorous research, development and manufacturing practices. We pride ourselves on fostering a culture of excellence, innovation and integrity, where our talented team members work collaboratively to achieve our vision of improving healthcare delivery.

Apply now

If you are a dedicated professional with a passion for sterilisation engineering and a commitment to regulatory compliance and product quality, we encourage you to submit your application. Please include your CV, a cover letter detailing your relevant experience, and any professional certifications. We look forward to hearing from you.