Assess and identify the need for changes in process automated systems and equipment. Assist with the development of system requirements and specifications to ensure requirements are testable and meet 21 Code Federal Regulations (CFR) Part 11 compliance. Assist in developing and executing CSV plans, test protocols, traceability matrices, release reports, and documents and deliverables within the scope of Automation Change Management. Develop collaborative partnerships with multiple site functions, including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives. Author, review and approve the SOP’s (Standard Operating Procedure) design specification documents and ensure changes comply with regulatory compliance (FDA 21 CFR Part 11) in document management system. Perform internal testing of software and hardware changes to ensure test results are per project scope using Rockwell Automation Factory Talk Software Technologies. Work under supervision. Travel and/or relocation to unanticipated client sites throughout USA is required.
