Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems.
Leads automation portion of expansion and upgrade projects. Ensures that all automation designs and technical documentation adhere to GMP standards.
Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements.
Develop and implement improved and robust control strategies for manufacturing processes.
Trains users on control system functionality (Programmable Logic Controller, Computer/ Control Networks, Control Computers, and Instrumentation).
Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology.
Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support of cGMP Manufacturing and Utility control systems.
Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.
Work cross-functionally with Validation, Facilities, Calibration, Manufacturing, Process, and Engineering efforts and other cross-functional departments requiring controls-related assistance and SME (Subject Matter Expert) expertise.
Maintains and optimizes the Calibration Data Base (Blue Mountain) as well as the Computerized Maintenance Management System (CMMS)
All other duties as assigned;
Qualifications
Bachelor’s degree in engineering with a minimum of 3+ years of related automation/ controls experience in a GMP pharmaceutical environment is required.
Experience with Rockwell/Allen-Bradley batch control systems is required. Experience with other control systems (Siemens, Schneider, etc.) is preferred.
Experience working in an FDA-regulated operation, preferably in the pharmaceutical/biotechnology area is required.
In-depth knowledge of PLCs, SCADA, HMI, Vision systems and Robotics along with proven ability to program PLCs and HMIs.
Working knowledge of ControlLogix, Panelviews, RSView SE, RSView ME, FactoryTalk, Control logix (RSLogix), Indusoft, Zenon, TIA Portal and EPAS-4
Understanding and knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.
Knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
