Senior Automation Engineer, Drug Product–Aseptic Filling

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Automation Engineering Job Category: Scientific/Technology All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Learn more and apply to this exciting new 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. Reporting to the Drug Product Manufacturing Lead within the Site Automation organization, the Automation Engineer, Drug Product – Aseptic Filling provides technical automation and controls engineering ownership for the assigned aseptic filling 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 role is responsible for the design, implementation, qualification, start-up, support, troubleshooting, and lifecycle management of automation solutions for Drug Product aseptic filling 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. Key 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. Travel domestically and internationally, as required, to supplier/OEM, system-integrator, and Johnson & Johnson affiliate sites for FAT, technical training, knowledge transfer, and automation readiness. 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. Qualifications Education: A minimum Bachelor's degree in Engineering, Computer Science, Science, or a related technical field; required Experience and Skills: Required: 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. Experie