Principal Engineer, Automation Engineering -Aseptic Filling SME

• ◆Own the filling line automation

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

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.
• ✓Maintain software baselines, configuration records, recovery procedures, and technical documentation. Guide supplier work, mentor engineers and technicians, and train operations and maintenance personnel on system behavior and fault recovery.

• ✓Bachelor’s degree in Electrical Engineering, Automation, Controls, Mechatronics, Computer Engineering, or a related technical discipline.

• ✓Minimum of 10 years of progressive automation and controls engineering experience in pharmaceutical or biopharmaceutical manufacturing.
• ✓Direct technical ownership of automated manufacturing systems in a cGMP environment, with hands-on responsibility for automation and controls scope supporting manufacturing operations and/or capital projects.
• ✓Proven Drug Product automation experience supporting aseptic or sterile manufacturing, including automated filling, inspection, assembly, packaging, or related highly automated systems.
• ✓Hands-o