Requirements Minimum of a Bachelors degree in biological sciences, biochemistry, pharmacy, engineering, biomedical engineering, pharmaceutical engineering, or closely related scientific or technical discipline plus minimum of 6 years experience as a Validation Engineer, Validation Specialist, Validation Supervisor or closely related in biopharmaceutical industry. Specific requirements Minimum 4 years of experience representing validation in change control process to manage introduction of new equipment and system and changes to existing systems. Must have 4 years experience in the author, review and approval of technical validation documents, such as Validation Master Plan, IOPQ protocols, and Validation Summary Reports. Must have 4 years of experience participating in risk assessment of the critical equipment and system. Must have 4 years of experience in investigation and resolution of deviations occurring during equipment and system qualification. Minimum 4 years experience participating in process flowSOP related to routine validation activity. Minimum 4 years experience with assessment and process performance qualification protocol for cellgene therapy manufacturing process.
Categories: eb3
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