Principal Automation Engineer Optical Inspection SME

Johnson & Johnson•Wilson, NC

1d•Onsite

About The Position

The Principal Automation Engineer will lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver operational technology infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment. The role owns vision requirements and inspection specifications across filling, automated visual inspection, device assembly, and packaging, defining scope and measurable acceptance criteria with Quality and equipment specialists and resolving supplier and integration gaps. The position requires hands-on development, qualification, commissioning, integration, troubleshooting, and lifecycle support of pharmaceutical automated visual inspection and PLC-integrated machine vision systems. The engineer will establish and maintain inspection methods and recipes, assess inspection performance, support validation and qualification, and ensure inspection results and product identity remain traceable. The role also leads investigations, coordinates OEM support, maintains technical documentation and recovery procedures, and trains and mentors colleagues. The position is based in Wilson, North Carolina, and requires full-time on-site support. During facility design, work will occur at an engineering firm and require frequent travel of more than 25%, until the project shifts to the Wilson plant site. Work includes integration, commissioning, qualification, and manufacturing support, including entry into controlled production areas using required gowning and safety procedures.

Requirements

Bachelor’s degree in Automation, Electrical Engineering, Computer Engineering, Computer Science, Optical Engineering, or a related technical discipline.
Demonstrated hands-on experience developing and qualifying pharmaceutical automated visual inspection and PLC-integrated machine vision systems through commissioning and GMP manufacturing support.
Experience configuring vision inspection tools for pattern matching, edge detection, feature measurement, defect classification, and recipe-based inspection, with controlled parameter limits and robust result handling.
Strong practical skills in optics, camera and lens selection, lighting, calibration, image processing, feature measurement, and defect detection, including control of presentation and environmental variation.
Ability to diagnose PLC and HMI interfaces, digital I/O, camera triggers, encoders, industrial Ethernet networks, product tracking, and reject control, including communication handshakes and timing.
Experience with presence and orientation checks, print verification, OCR/OCV, and one-dimensional and two-dimensional code reading and grading.
Experience with defect standards, challenge testing, statistical assessment of inspection performance, computerized system validation, requirements traceability, data integrity, deviations, and change control.
Ability to independently resolve complex inspection problems, communicate quality risks, coordinate suppliers, and guide colleagues through technical leadership without direct supervisory authority.
Ability to work on site during integration, commissioning, qualification, and manufacturing support, including entry into controlled production areas using required gowning and safety procedures.

Nice To Haves

Experience with robotic handling, automated setup, and vision-guided verification in device assembly and packaging.
Experience with MES, OPC UA, SQL, manufacturing historians, inspection image archives, and interfaces between vision results and serialization systems.
Experience supporting startup of a new pharmaceutical manufacturing facility, inspection process improvement, and regulatory inspection readiness.
Preferred skills include AI judgment and integration, artificial intelligence, continuous improvement, critical thinking, industry analysis, innovation, lean supply chain management, machine learning, management systems implementation, organizing, process improvements, project management, prototyping, quality assurance, robotic automation, STEM application, subject matter expert collaboration, and technical credibility.

Responsibilities

Lead internal teams, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders in delivering OT infrastructure and lifecycle initiatives in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, automated visual inspection, device assembly, and packaging.
Define inspection scope and measurable acceptance criteria with Quality and equipment specialists, and resolve supplier and integration gaps.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry.
Establish stable image acquisition across product formats, equipment speeds, and expected variation in materials and presentation.
Develop and maintain inspection jobs for particle and cosmetic defects, container and closure features, component presence and orientation, print verification, and barcodes, according to each station’s approved scope.
Integrate automated inspection equipment and inline vision systems with machine PLCs; verify trigger and result handshakes, product tracking, reject timing and confirmation, and line-stop behavior.
Develop defect libraries and challenge sets with Quality, and evaluate detection capability, false acceptance, false rejection, repeatability, and performance across formats and operating conditions using approved test methods.
Lead vision factory and site acceptance testing and commissioning.
Support qualification using traceable requirements, representative defect challenges, repeatability studies, and documented resolution of inspection and reject-system defects.
Troubleshoot missed triggers, poor images, incorrect recipes, product tracking errors, and communication failures; verify that stale, missing, or incomplete inspection results invoke the defined reject or stop response.
Define and verify batch context, inspection results, defect images, audit trails, and retention requirements with Quality and IT/OT.
Confirm that records and product identity remain traceable through interruptions and recovery.
Control inspection recipes, thresholds, calibration, software versions, and access permissions.
Assess camera, lens, lighting, algorithm, and firmware changes through risk assessment, change control, and appropriate requalification.
Lead investigations of inspection escapes, false rejects, and recurring faults; distinguish product defects from imaging, algorithm, handling, and timing problems, and implement corrective actions with Quality and Operations.
Maintain configuration backups, recovery procedures, and technical documentation.
Coordinate OEM support, mentor engineers and technicians, and train operators and maintenance personnel on inspection challenges, setup, and fault recovery.