Senior Automation Engineer, Drug Product–Aseptic Filling

About the role

The Automation organization is a dedicated team of professionals with diverse technical expertise responsible for the implementation, validation, qualification, and lifecycle support of ISA-95 Level 1 and Level 2 manufacturing automation systems, applicable interfaces, and Level 3 recipe and manufacturing-system integration. The team ensures that automated systems are fit for intended use and comply with applicable regulatory requirements, company manufacturing standards, data-integrity expectations, and cybersecurity requirements throughout the system lifecycle.

Responsibilities

• Serve as the area Automation Engineer for Drug Product aseptic filling 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 aseptic filling/finish operations and associated highly automated Drug Product equipment, including applicable isolator or barrier technologies, machine controls, batch/sequence control, SCADA/HMI, industrial networks, robotics, and 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, and test documentation to ensure alignment with site and global automation standards.
• Develop, implement, review, and troubleshoot PLC/DCS/HMI/batch and machine-control 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 Drug Product manufacturing 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 requirements while retaining technical ownership of the automation/controls solution. Translate approved process and equipment 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 an integrated and supportable solution.
• 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, system performance, validation efficiency, and manufacturing support.

Requirements

• Minimum of 6 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/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, OT infrastructure, and associated hardware and interfaces.
• Experience developing, reviewing, implementing, and troubleshooting automation software, system configurations, and engineering deliverables, including functional/design specifications, control narratives, interface definitions, alarm and interlock requirements, and system architectures.
• Proven automation project execution experience, including OEM and system integrator coordination, controls design reviews, FAT/SAT, commissioning, qualification, start-up support, troubleshooting, and automation change control.
• Solid understanding of ISA-88 and ISA-95 standards and their application within regulated manufacturing environments.
• Knowledge of cGMP and computerized system validation expectations, 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 partner optimally across Automation, Manufacturing, Process Engineering, Quality, CSV, OT Infrastructure, Digital, OEM, system integrator, and project teams while maintaining clear ownership of automation/controls deliverables.
• Ability and willingness to support project travel and on-site execution needs, including periodic international travel to supplier/OEM, system integrator, and Johnson & Johnson affiliate sites for training, FAT, automation testing, and related project activities.

Qualifications

• A minimum Bachelor's degree in Engineering, Computer Science, Science, or a related technical field.

Skills

• Experience with batch/sequence control, machine controls, robotics, motion control, and integration of aseptic filling equipment with MES and historian platforms.
• 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.