Department
Pharma
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- 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
Highest qualification: University
- 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;