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.

Yêu cầu công việc

BASIC Technical Skills:

- 1-2 years’ work experience in manufacturing. Experience in medical device is an advantage.

- Knowledge of medical device products & sterilization and/or 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

Quyền lợi

• Thưởng: 13th Monthly Salary, Full paid for Social Insurance, Medical Insurance, Competitive salary and Bonus
• Cơ hội du lịch: Travel opportunities
• Hoạt động nhóm: Company/Team outing trip, Annual Party