Principal Engineer, Automation Engineering -Aseptic Filling SME

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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.
• 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.

Qualifications

Education:

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

Experience and Skills:

Required:

• 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-on experience with ISA-95 Level 1 and Level 2 automation systems, including PLC and/or DCS controls, SCADA/HMI, batch or sequence control, machine controls, industrial networks, communication protocols, and OT infrastructure.
• Demonstrated hands-on automation experience with Bausch+Ströbel aseptic filling equipment and SKAN isolator and decontamination systems, including integration, commissioning, qualification, and GMP manufacturing support.
• Ability to explain and troubleshoot container flow through tub handling, e-beam transfer, aseptic filling, closure, rejection, and discharge, including the permissives and fault responses between equipment.
• Strong Siemens S7-1500 and TIA Portal programming and diagnostic skills, with working knowledge of Beckhoff controls and motion, Stäubli robot interfaces, instrumentation, and industrial networks.
• Working knowledge of B+S OVD/OMNIA and SKAN zenon applications, including recipe and batch control, alarm handling, audit trails, electronic signatures, and operator access.
• Experience diagnosing MES and historian interfaces, including OPC UA and SQL data flows, AVEVA PI connectivity, timestamps, buffering, and data recovery.
• Knowledge of aseptic process states, decontamination sequences, critical parameter controls, and environmental monitoring integration, with cGMP validation, risk assessment, data integrity, and change control experience.
• Ability to independently resolve complex line issues, assess product quality impacts with Quality and Sterility Assurance, coordinate suppliers, and guide engineers and technicians without direct supervisory authority.

Preferred:

• Experience with automated aseptic setup, robotic format changes, vision inspection, and material transfer qualification, including isolator or restricted-access barrier technologies.
• Experience supporting virtualized control applications, lifecycle upgrades, and IT/OT cybersecurity improvements for filling lines.
• Experience supporting startup of a new sterile manufacturing facility, aseptic process simulations, and inspection readiness.
• Experience delivering automation scope for a large pharmaceutical capital project from design through controls development, FAT/SAT, commissioning, qualification, start-up, and operational handover.
• Hands-on experience with platforms such as Rockwell Automation, Siemens, Emerson DeltaV, OSI PI, or Werum PAS-X, or comparable PLC, DCS, SCADA/HMI, historian, and MES technologies, including integration of aseptic filling equipment with MES and historian platforms.
• Experience with reliability engineering, automation lifecycle management, operational readiness, and maintenance/support strategy development.
• Good understanding of Industry 4.0, Industrial Internet of Things, advanced analytics, and evolving digital capabilities used to transform biopharmaceutical manufacturing.
• Experience working with multiple OEMs, engineering partners, automation vendors, and system integrators in a global or multi-site organization.

Other:

• This position is based in Wilson, North Carolina, and requires full-time on-site support. Facility design will take place at an engineering firm, so frequent travel (more than 25%) is required until the project transitions to the Wilson, NC plant site.

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