Validation Engineer / Senior

Overall Purpose of the Job: Responsible for the conducts of the validation plan and processes for facilities, laboratory equipment, utility systems and process equipment, writes reports that reflect the validation was performed. Primary Tasks: Write validation protocols and reports. Perform validation activities described in validation protocols including thermal studies, equipment and utilities validation. Maintain an up to date knowledge of validation requirements, practices and procedures. Work with validation and metrology contractors when required. Interact with manufacturing sciences and facilities / engineering departments to facilitate protocol execution as necessary. Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval. Good technical writing skills Able to read P&ID, Isometric and "as built" drawings. Communicate effectively with supervisor and other department's workload, priorities, and issues to maintain validation schedule. Filter validation. Sterility validation.

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