Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
Coordinates activities with clients, programmers / developers and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
Reports on the status of validation activities to fulfill regulatory requirements.
Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Bachelor’s degree in Science or Engineering is required, Engineering will be preferred.
At least minimum of 2 years of relevant experience in quality engineering or validation engineering is required.