Principal Automation Engineer Optical Inspection SME

Johnson & Johnson Innovative Medicine•Wilson, NC

3d•Onsite

About The Position

Johnson & Johnson is seeking a Principal Automation Engineer with optical inspection subject-matter expertise to support pharmaceutical manufacturing. The role leads internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders in delivering automation and vision inspection systems in a cGMP manufacturing environment. The position owns vision requirements and inspection specifications across filling, automated visual inspection (AVI), device assembly, and packaging, defining inspection scope and measurable acceptance criteria with Quality and equipment specialists. The engineer develops, integrates, qualifies, commissions, and supports PLC-integrated machine vision systems. This includes establishing reliable image acquisition and inspection performance across formats and operating conditions; integrating inspection results with machine control and reject systems; and ensuring inspection records, product identity, and audit trails remain traceable. The role also controls inspection configurations and changes, leads troubleshooting and investigations, maintains documentation and recovery procedures, coordinates suppliers, and provides technical guidance and training. The position is based in Wilson, North Carolina, and requires full-time on-site support. Facility design will take place at an engineering firm, with frequent travel (more than 25%) required until the project shifts to the Wilson plant. Work includes integration, commissioning, qualification, and manufacturing support, including entry into controlled production areas under required gowning and safety procedures.

Requirements

Bachelor’s degree in Automation, Electrical Engineering, Computer Engineering, Computer Science, Optical Engineering, or a related technical discipline.
At least 10 years of progressive experience in manufacturing OT infrastructure, industrial automation infrastructure, or closely related regulated manufacturing systems, with direct responsibility for OT architecture, implementation, integration, troubleshooting, and lifecycle support.
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.
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 in Wilson, North Carolina, and travel frequently (more than 25%) during the facility design phase.

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.

Responsibilities

Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders in delivering automation and vision inspection systems in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, AVI, device assembly, and packaging; define inspection scope and measurable acceptance criteria with Quality and equipment specialists.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry to establish stable image acquisition across product formats, equipment speeds, and expected variation.
Develop and maintain inspection jobs for particle and cosmetic defects, container and closure features, component presence and orientation, print verification, and barcodes according to approved station 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.
Lead vision factory and site acceptance testing and commissioning; support qualification with 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 defined reject or stop responses for stale, missing, or incomplete inspection results.
Define and verify batch context, inspection results, defect images, audit trails, and retention requirements with Quality and IT/OT, ensuring 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.
Work on site during integration, commissioning, qualification, and manufacturing support, including in controlled production areas using required gowning and safety procedures.