Specialist, Automation Engineering
Core
End-to-end automation engineering support for sterile clinical manufacturing (formulation, filling, lyophilization) in a cGMP facility, ensuring reliable and compliant operation of OT/IT systems.
Role type
Specialist, Automation Engineering (IC)
Builds
Sterile clinical supply products (small molecules, biologics, vaccines, ADCs) for patient access
Domain
Biopharmaceutical manufacturing / Clinical supply chain
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
cGMP compliance, PLC/SCADA fundamentals, industrial networking, change control, root cause analysis, system administration, cybersecurity basics, validation principles
Preferred skills
Allen-Bradley/Siemens PLCs, SCADA (iFix/WinCC OA/Ignition), Python scripting, S88 batch standards, biologics/vaccine manufacturing experience, OT/IT virtualization, electronic validation systems
Technologies
Allen-Bradley, Siemens, iFix, WinCC OA, Ignition, OPC, ASI, Profibus, Profinet, DeviceNet, Historian/SCADA, Python, Kneat/eVal, Veeva
Responsibilities
Maintain validated automation systems per cGMP and data integrity standards; troubleshoot controls, instrumentation, electrical, and software layers; lead installation, integration, and qualification of new automated equipment; execute change control and risk assessments; represent automation in capital projects; supervise contract engineers and vendors; develop data reporting and visualization solutions.
Seniority
Specialist, hands-on IC
