1. Ensures the timely validation of equipment, processes, and new product according to the validation master plan.
2. Responsible for writing validation protocols and reports according to the validation master plan.
3. Revises the validation master plan when substantial changes are made to ensure timely updates.
4. Ensures that validation FMEAS (failure mode effect analysis) are performed as required in order to reduce the risk of failure during validation.
5. Performs studies during validations as required in order to demonstrate process capability.
6. Responsible for performing internal audits to ensure compliance of the site’s quality, environmental, and health and safety systems to international standards.
7. Must perform environmental duties such as segregation of waste and following GMPs (Good Manufacturing Practices) in order to comply with ISO 14001.
8. Must comply with company health and safety procedures and policies and must immediately report any unsafe conditions to ensure a safe workplace.
9. Implement group and site environmental and health and safety: policies, objectives, and other related requirements of the ISO14001 environmental and OHSAS 18001 health and safety management systems.

1. B.S. degree in science
2. Good English/Chinese communication skills.
3. Prior experience in a manufacturing environment desired.
4. Prior validation experience desired.
5. ISO9001 experience desired.