The Validation Engineer is responsible for overseeing and maintaining validation programs and insuring validation plans are properly implemented in compliance with corporate and regulatory requirements. The Validation Engineer is also responsible for site-wide compliance of the activities related to validation and performs work lead responsibilities.
The Validation Engineer reports into the Quality Assurance area and interacts daily with Quality and Manufacturing Engineers to insure compliance of the validation program. The incumbent conveys validation policies and procedures to regulatory bodies such as the FDA and other notified bodies. While monitoring and carrying out the validation program, the Validation Engineer makes improvements to the program as needed, and makes presentations to management when changes need to be made to the program or in association with key projects.
The Validation Engineer works within the validation policies established by the company. Key to these policies is an understanding of the national and international organizations that define the quality requirements for validation. The Validation Engineer will report changes in these requirements and make changes to the validation policy where needed. The Validation Engineer may be assigned to special projects that are commensurate with his or her level of experience.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES