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Have familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure. Creation, modification, and maintenance of automation system documentation.
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Primarily responsible for the direction, organization, and supervision of all clean and/or grey utilities maintenance operations and functions; this position is responsible for assisting the Facilities Maintenance Management with the administration of the department, including strategic and budgetary planning, along with the development of new initiatives and the implementation of operational improvements.
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Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.
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