
- Bachelor degree in computer software, industrial, mechanical engineering or electrical engineering.
- 3 - 5 years of IT computer validation with experience in medical device manufacturing operation
- Experience in a regulated environment with in depth knowledge and experience with cGMPs/GLPs/GAMP regulations related to medical device manufacturing systems, CFR Part 820, 210, 211, 21 CFR Part 11, ISO 13485, ISO 14971.
- Training in validation methodologies, technologies and process control computer systems.
- Very good command of written & spoken English.
Working Location
- Chonburi