Validation Engineer I (Sterilization Validation)

About the role

The Validation Engineer I will support the sterilization validation of medical devices, ensuring compliance with regulatory standards and product quality. You will work closely with vendors across Asia and internal teams to manage sterilization processes and product releases.

Key responsibilities

• Prepare and execute sterilization validation activities for medical devices, including ETO and steam methods.
• Manage sterilized product release and maintain sterilization processing agreements.
• Perform validation studies to assure sterility of devices from Asian suppliers.
• Document validation results and ensure alignment with regulatory requirements.

Required profile

• 1‑2 years of manufacturing experience; experience in medical devices is a plus.
• Knowledge of medical device and sterilization or packaging regulations and standards.
• Fluent in spoken and written English.
• Professional attitude with a strong sense of urgency and accuracy.
• Ability to work effectively in a team environment.

Required skills

• Sterilization Regulations
• MS Office
• Product Validation
• Statistical Software