Specialist, Automation Engineering - 2nd Shift (Onsite)
Core
Provide 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 drug products (small molecules, biologics, vaccines, ADCs) for clinical supply and development
Domain
Biopharmaceuticals / Clinical Supply Manufacturing / GMP
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
cGMP compliance, validation principles, PLC/SCADA fundamentals, industrial networking, root cause analysis, change control, system administration, cybersecurity basics, data integrity
Preferred skills
Allen-Bradley/Siemens PLCs, SCADA (iFix/WinCC OA/Ignition), Ladder Logic, Python scripting, S88 batch standards, biologics/vaccine manufacturing experience, OT/IT virtualization, electronic validation systems (Kneat/eVal/Veeva), capital project experience
Technologies
PLCs, SCADA, OPC, fieldbuses (ASI/Profibus/Profinet/DeviceNet), Historian/SCADA sources, VMs, databases
Responsibilities
Maintain validated automation systems per cGMP and lifecycle best practices; 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 and audits; develop data reporting and visualization solutions; supervise contract engineers and vendors.
Seniority
Specialist, hands-on IC