The Automation Engineer is responsible for overseeing and optimizing automation systems to improve production efficiency and reduce operational costs. This position involves designing, integrating, and implementing advanced hardware and software solutions within pharmaceutical manufacturing 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:
Assists with engineering projects and performs other duties as assigned.
Numbers & Facts
Location
Piscataway, NJ
Skills
Acceptance Testingunmatched
Analysis Skillsunmatched
Automationunmatched
Automation Engineeringunmatched
Automation Systemsunmatched
Biotech and Pharmaceuticalunmatched
CIP (Clean-in-Place)unmatched
Calibrationunmatched
Change Controlunmatched
Coding Standardsunmatched
Commissioningunmatched
Constructionunmatched
Control Systemsunmatched
Cost Controlunmatched
Documentationunmatched
Drug Manufacturingunmatched
Electricityunmatched
Engineeringunmatched
Formal Verificationunmatched
GMP (Good Manufacturing Practices)unmatched
Hardware Design and Simulation Softwareunmatched
Laboratory Equipmentunmatched
Logisticsunmatched
Manufacturingunmatched
OEM (Original Equipment Manufacturer)unmatched
On Callunmatched
Operational Strategyunmatched
Operations Processesunmatched
Preventative Maintenanceunmatched
Process Validationunmatched
Production Systemsunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Research & Development (R&D)unmatched
SIP (Sterilization-in-Place)unmatched
Standards Developmentunmatched
Startupunmatched
Support Documentationunmatched
System Testunmatched
System Validationunmatched
Technical Supportunmatched
Test Plan/Scheduleunmatched
Testingunmatched
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