Principal Engineer, Automation Engineering -Aseptic Filling SME

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Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

About Innovative Medicine

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Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Learn more and apply to this exciting new role!

The Automation Engineer will serve as the subject matter expert (SME) for the integrated aseptic vial and syringe filling lines for Project Eagle in Wilson, North Carolina. This role requires hands-on expertise with Bausch+Ströbel fillers, SKAN isolator and e-beam systems, and their automation platforms, as well as their interfaces with robotics, environmental monitoring, and site manufacturing and data systems.

The engineer will exercise independent technical judgment, resolve complex automation issues, and provide technical leadership to suppliers, engineers, and technicians. The role partners with Manufacturing, Process Engineering, Sterility Assurance, Quality, IT/OT, and qualification teams to protect product quality and sustain reliable operation under current Good Manufacturing Practice (cGMP).

Key Responsibilities:

• Own the filling line automation requirements and functional design. Review Bausch+Ströbel and SKAN specifications, control narratives, interface definitions, and supplier designs, and close gaps between equipment packages and site systems.
• Develop, review, and troubleshoot Siemens PLC and HMI/SCADA applications for container handling, dosing, fill weight control, stoppering and closure, reject verification, and line sequencing. Diagnose Beckhoff motion and Stäubli robot interfaces in partnership with equipment specialists.
• Own the interfaces between the Bausch+Ströbel filler and the SKAN isolator, e-beam, decontamination, and material transfer controls. Verify operating modes, equipment handshakes, stop conditions, and restart permissives across the integrated line.
• Translate aseptic processing and contamination control requirements into automation logic with Sterility Assurance and Process Engineering, covering isolator pressure and airflow, decontamination status, environmental sampling, product exposure limits, and intervention controls.
• Configure and verify recipes, critical parameter limits, alarms, batch sequencing, and protected operator actions across B+S OVD/OMNIA and SKAN zenon applications, ensuring consistent line behavior, controlled overrides, and documented approvals.
• Lead automation factory and site acceptance testing (FAT/SAT) and commissioning. Support installation, operational, and performance qualification and aseptic process simulations with traceable requirements, challenge tests, and documented resolution of defects.
• Implement and troubleshoot interfaces to manufacturing execution systems (MES), AVEVA PI, environmental monitoring, and reporting systems. Verify batch identifiers, OPC UA and SQL data flows, communication watchdogs, buffering, and recovery under fault conditions.
• Verify audit trails, electronic signatures, user access, time synchronization, and backup and restore with Quality and IT/OT, confirming that filling batch, isolator campaign, decontamination, and environmental monitoring records are complete and retrievable.
• Evaluate controls and safety interfaces with the appropriate specialists. Test responses to communication loss, power interruptions, equipment faults, and emergency stops, including restart permissives and any required restoration of the aseptic process state.
• Lead complex troubleshooting and root cause investigations. Assess automation contributions to deviations, implement corrective actions through change control, and drive improvements in filling performance, reject rates, availability, and recovery time.

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