Senior Specialist, Automation Engineering (Onsite)
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
Senior Specialist, Automation Engineering (Onsite)
Builds
Sterile clinical supply products (small molecules, biologics, vaccines, ADCs) for patient delivery
Domain
Pharmaceutical manufacturing (cGMP, sterile clinical supply)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure | physical/clinical work
Required skills
cGMP compliance, automation lifecycle management, PLC/SCADA troubleshooting, industrial networking, change control, root cause analysis, system administration, vendor management
Preferred skills
Allen-Bradley/Siemens PLCs, SCADA (iFix/WinCC OA/Ignition), Python scripting, S88 batch standards, biologics/vaccine manufacturing experience, electronic validation systems (Kneat/eVal/Veeva), capital project management
Technologies
PLCs, SCADA, OPC, fieldbuses (ASI/Profibus/Profinet/DeviceNet), historian/SCADA sources, virtualization, databases
Responsibilities
Maintain validated automation systems per cGMP and data integrity standards; provide on-floor troubleshooting and root cause analysis for sterile manufacturing; lead installation, integration, and qualification (AIOQ) of new automated equipment; represent automation in capital projects and audits; develop data reporting and visualization solutions; supervise contract engineers and vendors.
Seniority
Senior, hands-on IC with leadership responsibilities
