About the role
The Automation Lead will be a key member of the Engineering Department and serve as the primary automation Subject Matter Expert (SME) for the sterile manufacturing facility. This role will be responsible for the design, implementation, commissioning, qualification, maintenance, and lifecycle management of automation and control systems supporting sterile manufacturing operations.
What they're looking for
- Serve as the primary automation SME for the sterile manufacturing facility, including automation and control systems for sterile manufacturing equipment, Environmental Monitoring Systems (EMS), and GMP utility systems
- Serve as the automation SME for critical utility systems, including WFI generation and distribution, clean steam, compressed air, nitrogen, and other applicable GMP utilities
- Support product technology transfer and scale-up activities by ensuring appropriate automation recipes, control strategies, system interfaces, and electronic data requirements are established and maintained
- As a member of the global engineering team, actively connect with and contribute to global automation and digital engineering projects, standards, planning, and implementation
- Provide technical guidance and coaching to automation engineers and other technical staff
- Foster strong cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, and Program Management teams
More about this role
The Automation Lead will be a key member of the Engineering Department and serve as the primary automation Subject Matter Expert (SME) for the sterile manufacturing facility. This role will be responsible for the design, implementation, commissioning, qualification, maintenance, and lifecycle management of automation and control systems supporting sterile manufacturing operations.
The primary scope of responsibility includes automation systems for sterile manufacturing equipment, Environmental Monitoring Systems (EMS), and automation of critical utility systems, including Water for Injection (WFI) generation and distribution, clean steam, compressed gases, and other applicable GMP utility systems. The Automation Lead will support the automation lifecycle from system design and vendor coordination through FAT, SAT, commissioning, qualification, start-up, routine operation, troubleshooting, cybersecurity, and continuous improvement.
This position is an individual contributor role with no direct reports.
- Serve as the primary automation SME for the sterile manufacturing facility, including automation and control systems for sterile manufacturing equipment, Environmental Monitoring...
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