Senior Automation Engineer, Optical Inspection/Device Assembly

Johnson & Johnson Innovative Medicine•Wilson, NC

7d•Onsite

About The Position

Reporting to the Drug Product Manufacturing Lead within the Site Automation organization, the Automation Engineer, Drug Product – Optical Inspection / Device Assembly provides technical automation and controls engineering ownership for the assigned inspection and device-assembly area. This is an automation engineering role with direct accountability for manufacturing control systems and automation delivery; Process Engineering is a key partner but is not the functional scope of this position. The Senior Automation Engineer, is responsible for the design, implementation, qualification, start-up, support, troubleshooting, and lifecycle management of automation solutions for Drug Product optical/visual inspection and device assembly operations and their interfaces to site manufacturing systems. The engineer will work closely with Manufacturing, Process Engineering, Quality, Computerized System Validation (CSV), OT Infrastructure, MES, Digital, equipment suppliers, OEM controls teams, and system integrators.

Requirements

A minimum Bachelor's degree in Engineering, Computer Science, Science, or a related technical discipline; required
A minimum of 6 years of progressive industrial automation and controls engineering experience within pharmaceutical or biopharmaceutical manufacturing. Experience must include direct technical responsibility for automated manufacturing systems in a cGMP environment; general manufacturing, process engineering, or equipment engineering experience without substantive automation/controls responsibility does not meet this requirement.
Hands-on technical experience with ISA-95 Level 1 and Level 2 manufacturing automation systems, including PLC and/or DCS controls, SCADA/HMI, batch or sequence control, machine controls, industrial networks and communication protocols, OT infrastructure, and associated hardware and interfaces.
Proven experience developing, reviewing, implementing, and troubleshooting automation software/configuration and related engineering deliverables such as functional/design specifications, control narratives, interface definitions, alarm/interlock requirements, and system architectures.
Proven automation project execution experience, including OEM and system-integrator technical coordination, controls design reviews, FAT/SAT, commissioning, qualification, start-up support, troubleshooting, and automation change control.
Knowledge of ISA-88 and ISA-95 standards and their application within a regulated manufacturing environment.
Knowledge of cGMP and computerized-system validation requirements, including GAMP 5, 21 CFR Part 11, EU GMP Annex 11, data integrity, and risk-based validation principles.
Experience integrating manufacturing automation with Level 3 systems such as MES, historian, recipe management, data platforms, and related business or quality systems.
Strong written and verbal communication skills with the ability to work effectively with Automation, Manufacturing, Process Engineering, Quality, CSV, OT Infrastructure, Digital, OEMs, system integrators, and project teams while maintaining clear ownership of the automation/controls scope.
Ability to support the project travel and on-site expectations established for the design, construction, start-up, and steady-state phases of the role.
Demonstrated Drug Product automation experience supporting pharmaceutical inspection, device assembly, packaging, filling/finish, or closely related sterile manufacturing operations is required. Experience must include direct automation/controls responsibility; experience limited to process engineering, validation, manufacturing operations, or equipment engineering without hands-on automation responsibility does not satisfy this requirement.
Technical knowledge of highly automated machine-control applications, including PLC/SCADA/HMI, vision/inspection systems, servo/motion control, robotics, industrial networks, and integration with site manufacturing systems.

Nice To Haves

Direct automation engineering experience with pharmaceutical optical or visual inspection systems, device assembly equipment, machine vision, robotics, servo/motion control, or closely related highly automated Drug Product equipment.
Experience integrating vision/inspection and machine-control systems with MES, historian, data platforms, and electronic traceability solutions.
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, Werum PAS-X, or comparable PLC, DCS, SCADA/HMI, historian, and MES technologies.
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

Serve as the area Automation Engineer for Drug Product optical/visual inspection and device assembly and provide direct technical ownership of the automation/controls scope under the DP Manufacturing Lead.
Support end-to-end automation delivery from concept and detailed design through controls development, FAT/SAT, construction support, commissioning, qualification, start-up, handover, troubleshooting, and steady-state lifecycle support.
Provide technical oversight for automation solutions supporting optical and visual inspection, device assembly, robotics, machine controls, servo/motion control, vision/inspection systems, SCADA/HMI, industrial networks, and associated site-system interfaces.
Review and challenge OEM and system-integrator automation designs, software/configuration, functional and design specifications, control narratives, system architectures, interface definitions, alarms/interlocks, inspection/vision-system requirements, and test documentation to ensure alignment with site and global automation standards.
Develop, implement, review, and troubleshoot PLC/HMI, machine-control, motion, robotics, and vision/inspection-system changes within the assigned area; ensure software and configuration are maintainable, standardized, documented, and appropriately controlled.
Plan, support, and execute automation FAT/SAT, commissioning, qualification, and start-up activities; lead technical issue resolution and drive automation punch-list items to closure.
Support automation interfaces to MES, historian, recipe/data platforms, and other site systems; ensure reliable data flow, traceability, and system integration for inspection and device-assembly operations.
Author, review, and execute automation-related validation and qualification documentation; support risk assessments, investigations, deviations, CAPA, change controls, and regulatory/internal inspections.
Apply sound automation engineering principles, cGMP requirements, GAMP 5 practices, data-integrity expectations, cybersecurity controls, and lifecycle-management standards throughout the system lifecycle.
Partner with Manufacturing and Process Engineering on process and equipment requirements while retaining technical ownership of the automation/controls solution. Translate approved requirements into robust, testable automation functionality.
Coordinate technically with equipment vendors, OEM controls teams, system integrators, CSV, OT Infrastructure, MES, Digital, Quality, and other partners to deliver integrated and supportable inspection and device-assembly systems.
Support operational readiness through training, documentation, maintenance/support models, spare-parts considerations, disaster-recovery/business-continuity planning, and transfer of automation-system knowledge to the site organization.
Use automation performance data and operational experience to identify continuous-improvement opportunities in reliability, inspection-system performance, system availability, validation efficiency, and manufacturing support.