Sterilization Engineer (Kỹ sư tiệt trùng)
Quận 3, Hồ Chí Minh (On-site)
Nghỉ trọn T7, CN
Hạn chót 27/11/2026
Đăng 15 ngày trước
Yêu cầu công việc
Technical Skills:
- 1-2 years’ work experience in Quality manufacturing settings. Experience in medical device is an advantage.
- Knowledge of ETO/Steam sterilization processes and packaging related regulations and standards.
- Fluent at both verbal and written English.
- Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
- Good teamwork spirit and problem-solving skills.
- Willing to travel with rate 50%
- Proficiency of PC skills: MS Office Software, Statistical Software
Qualification:
- Education level: Bachelor’s degree or above with science or engineering background. Biological and chemical background is a plus.
- Familiar with requirements and standards related to ISO11135, ISO11607, ISO13485 or ISO17025 is preferred.
- Project Management skill is a plus
Yêu cầu nên có
Experience in medical device manufacturing Biological or chemical educational background Familiarity with requirements and standards related to ISO 11135 Familiarity with requirements and standards related to ISO 11607 Familiarity with requirements and standards related to ISO 13485 Familiarity with requirements and standards related to ISO 17025 Project management skills
Công việc cụ thể là gì?
JOB SUMMARY:
- Prepare and execute sterilization validation related activities for medical device.
- Execute sterilized product release and sterilization processing agreement management.
CORE JOB RESPONSIBILITIES:
- Perform validations related to sterility assurance of sterile medical devices from vendors in Asia, including but not limited to
+ ETO sterilization validation
+ Steam sterilization validation
+ Packaging validation
- Supervise and train vendors for ISO standards and Medline requirements
- Perform audits and vigilance audits for sterile products related quality system and process; follow up CAPA/ SCAR and ensure appropriate evidence in a timely manner
- Perform root cause investigation, troubleshooting and problems solving when non-expected situation happens.
- Perform new products adoption into validated sterilization cycle including but not limited to bioburden, residual evaluation, packaging evaluation, etc.
- Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross-functional teams.
- Intensive travels to vendors to ensure meeting quality requirements.
- Other work assigned by supervisor.
• Ngày làm việc: T2 - T6 • Giờ làm việc: 08:00 - 17:00 • Cấp bậc: Nhân viên (associate) • Loại công việc: Toàn thời gianQuyền lợi có gì?
Lương thưởng
13th Monthly Salary, Full paid for Social Insurance, Medical Insurance, Competitive salary and Bonus
Văn hoá công ty
Company/Team outing trip, Annual Party
