Under general supervision, determines the critical aspects of manufacturing equipment with regard to product and process, and writes protocols and other records related test results. Prepares final reports that identify the results of protocol testing and the conditions of release. Assists in conducting efficiency studies and in the identification of process improvement opportunities. Participates in project coordination activities.
and state, federal and local laws.
requirements for new and current products.
related to validation protocols are met.
reports as required upon failures to meet protocol acceptance criteria.
Bachelor’s degree in Science or related field from an accredited college or university and one (1) to two (2) years’ experience; or an equivalent combination of education and experience. Graduate degree preferred.
Knowledge of or ability to learn current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.