Sr. Automation Engineer - Packaging
Core
System Owner for critical automation assets in a GMP-regulated aseptic drug product manufacturing facility, responsible for lifecycle management, troubleshooting, and continuous improvement.
Role type
Senior IC automation engineer (biopharmaceutical manufacturing)
Builds
Automated drug product manufacturing systems (Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Packaging)
Domain
Biopharmaceutical manufacturing / Industrial automation
Required skills
PLC/HMI programming, SCADA systems, Fieldbus protocols, GAMP software development lifecycle, Change Control management, Root cause analysis, Regulatory compliance (21 CFR Part 11, Annex 11), Network architecture (TCP/IP, Firewalls)
Preferred skills
Biopharmaceutical Formulation or Vial/Syringe Filling experience, Inspection or Packaging facility experience, Siemens and Rockwell PLC/HMI expertise, iFix/InTouch/Zenon/FTView SCADA knowledge, Industry 4.0 initiatives (data integration, digital twins)
Technologies
Siemens, Rockwell, iFix, InTouch, Zenon, Process Control Systems, Rockwell FTView SCADA, ControlNet, DeviceNet, Profibus, ProfiNet, AS-I, BACnet, TCP/IP
Responsibilities
Oversee lifecycle maintenance and validation of automation systems in a GMP environment; Manage Change Controls, Deviations, and CAPAs; Provide on-the-floor and remote technical support during production and shutdowns; Lead incident investigations and root cause analyses; Implement software changes and updates to design documentation and SOPs; Champion Industry 4.0 initiatives including data integration and digital twin technologies.
Seniority
Senior, hands-on IC
