Principal Engineer, Automation Engineering -Aseptic Filling SME

Johnson & Johnson•Wilson, NC

3d•Onsite

About The Position

The Principal Engineer, Automation Engineering will serve as the subject matter expert for Project Eagle’s integrated aseptic vial and syringe filling lines in Wilson, North Carolina. The role requires hands-on expertise with Bausch+Ströbel fillers, SKAN isolator and e-beam systems, their automation platforms, and 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 position 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). It owns filling-line automation requirements and functional design, supports integration and qualification, and maintains software baselines, configuration records, recovery procedures, and technical documentation. It also guides supplier work, mentors engineers and technicians, and trains operations and maintenance personnel. The role 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 plant site.

Requirements

Bachelor’s degree in Electrical Engineering, Automation, Controls, Mechatronics, Computer Engineering, or a related technical discipline.
At least 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, including hands-on responsibility for automation and controls supporting manufacturing operations and/or capital projects.
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.
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 equipment permissives and fault responses.
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 experience in cGMP validation, risk assessment, data integrity, and change control.
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.
Full-time on-site support in Wilson, North Carolina, with frequent travel (more than 25%) required until the project transitions to the Wilson plant site.

Nice To Haves

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 Rockwell Automation, Siemens, Emerson DeltaV, OSI PI, Werum PAS-X, or comparable PLC, DCS, SCADA/HMI, historian, and MES technologies, including aseptic filling equipment integration 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.

Responsibilities

Own filling-line automation requirements and functional design; review supplier specifications, control narratives, interface definitions, and designs, and resolve 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 interfaces between the Bausch+Ströbel filler and 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, including 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; ensure 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 using traceable requirements, challenge tests, and documented defect resolution.
Implement and troubleshoot interfaces to 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, ensuring records are complete and retrievable.
Evaluate controls and safety interfaces with appropriate specialists; test responses to communication loss, power interruptions, equipment faults, and emergency stops, including restart permissives and restoration of the aseptic process state where required.
Lead complex troubleshooting and root-cause investigations; assess automation contributions to deviations, implement corrective actions through change control, and improve 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.