Sr. Automation & Validation Engineer

SR. AUTOMATION & VALIDATION ENGINEER Location Remote in Chicago, IL : Duties and Responsibilities: Lead the designing and development of manufacturing control systems in support of process operations. Interact with client personnel to identify and analyze continuous improvement through automation upgrades. Manage or support projects as the primary controls resource. Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Design, program, test and validate process control automation systems. Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements. Manage, document, and implement these upgrades through changes control procedures. Manage the activities of on-site project resources; define detailed plan necessary to complete approved projects on schedule and within budget. Design, develop, and implement technical solutions by establishing integration strategies, configuring, and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels, and field devices. Manage capital projects including but not limited to: Control system software development Control system hardware design Network design MES system implementation Recipe management User requirement specification development Process equipment installations. SOP development and training on Automation Systems. Troubleshoot, analyze, and resolve field control system issues. Develop, review, and / or execute automation qualification and validation protocols. Qualifications: We require a minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical, etc.) or equivalent with over 5 years' experience in process industry. Experience/Knowledge of selecting, designing, and programming automation control systems. Startup and commissioning of DCS, Batch, PLC and SCADA systems using distributed I/O. PLC/SCADA Experience: 5+ years of Allen-Bradley, Rockwell Automation Studio 5000 & FactoryTalk. Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS. Experience in following CSV methodology for system evaluations, changes, and implementations.