Validation Engineer I (Kỹ sư thẩm định tiệt trùng)

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.