Senior Validation Engineer 高级验证工程师

Job Responsibilities:

1. Work as project manager and perform validations related to sterility assurance of sterile medical devices from vendors in Asia, including but not limited to

a. ETO sterilization validation (ISO11135)

b. Steam sterilization validation (ISO17665)

c. Packaging validation (ISO11607)

2. Supervise and train vendors for ISO standards and Medline requirements;

3. Perform audits per QSR820/ISO and Medline requirements, and vigilance audits for sterile products related quality system and process; follow up CAPA/ SCAR and ensure appropriate evidences in a timely manner;

4. Perform root cause investigation, troubleshooting and problems solving when non-expected situation happens;

5. Perform package and sterilization mass production phase quality control , perform process optimize control;

6. Give employee EO sterilization validation and steam validation training;

7. Perform new products adoption into validated sterilization cycle including but not limited to bioburden, residual evaluation, packaging evaluation, etc;

8. Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross-functional teams;

9. Intensive travels to vendors to ensure meeting quality requirements;

10. Other work assigned by supervisor.

Qualifications:

1. Bachelor’s degree or above with Biological, chemical, science or engineering background is preferred;

2. 3-8 years’ work experience in manufacturing or medical device industry is preferred;

3. Good command of both verbal and written English;

4. Project management skill and experience;

5. Microsoft Word and Excel experience at an intermediate level;

6. Willing to travel with rate 30-50%;

7. Good teamwork spirit, Good problem solving skills;

8. Familiar with requirements and standards related to ISO11135, ISO11607 is preferred.