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Job Summary
The Automation Engineer II is responsible to monitor and improve automation processes for optimum cost efficiency of production. This role will design, integrate, and implement pharmaceutical manufacturing hardware and software throughout the facilities.
Essential Functions
Develop Control Systems based on coordination with OEM, in order to automate upstream and downstream processing equipment, including Mixers, Coaters, Pouchers, Cartoners, Packaging Lines, Laboratory equipment, facility systems, stability Chambers, BMS, CIP (Clean in Place) and SIP (Steam in Place), Water System Controls, Tablet Press, Fluid Bed Dryers, Granulators, Vision System etc.
Perform programming, qualification and validation of digital process automation systems. Provide 24x7 on-call Automation Support, including technical support and troubleshooting functions. Perform formal systems acceptance testing, including software simulation and hardware and equipment acceptance in pharmaceutical manufacturing facilities.
Properly complete documentation for accurate recordkeeping, according to the Engineering Department's procedures, Assist with updating departmental procedures; monitor equipment, and ensure preventative maintenance is being done, handle calibration monitoring, engineering analysis. Assist with training coworkers on using equipment.
Read, understand, verify and develop P&ID, Engineering Layout, Engineering Drawings and Engineering documents.
Implement projects according to Good Automated Manufacturing Practice (GAMP) guide for validation of automated systems in pharmaceutical manufacture.
Handle logistics and coordination of electrical construction activities as per engineering standards, vendor development, with the various departments like manufacturing, QA, QC, R&D for the engineering and Validation Aspects; maintain VMP and other GMP documents, Support Process Validation and Development Studies. Coordinate and ensure Safety Aspects.
Perform hands on field installation, operational start-up, calibration, and commissioning activities.
Support Change Control Management, updating documentation for client, including test plans and production implementation.
Apply batch coding standards to automation process, including design of batch operations, unit procedures, and procedural recipe components to aforementioned processes.
Additional Responsibilities