11 часов назад
Senior Automation Engineer, Drug Product–Aseptic Filling (Pharmaceutical Manufacturing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Automation Engineer, Drug Product–Aseptic Filling (Pharmaceutical Manufacturing): Designing, implementing, qualifying, and supporting automation and controls systems for drug product aseptic filling operations with an accent on cGMP compliance, ISA-95 Level 1/2 systems, and manufacturing-system integration. Focus on developing and troubleshooting PLC/DCS/HMI and batch controls, executing FAT/SAT and commissioning, and integrating MES, historian, robotics, and industrial networks.
Location: Wilson, North Carolina, United States; full-time on-site support required. The role requires frequent domestic and international travel exceeding 25% during facility design until the project shifts to the Wilson plant site.
Company
Johnson & Johnson MedTech develops healthcare and medical solutions designed to prevent, treat, and cure complex diseases.
What you will do
- Own the automation and controls scope for drug product aseptic filling operations.
- Deliver automation solutions from concept and detailed design through controls development, FAT/SAT, commissioning, qualification, start-up, handover, and lifecycle support.
- Develop, implement, review, and troubleshoot PLC, DCS, HMI, batch, sequence, and machine-control changes.
- Review OEM and system-integrator designs, specifications, architectures, interfaces, alarms, interlocks, and test documentation.
- Integrate automation with MES, historians, recipe and data platforms, industrial networks, and other site systems.
- Coordinate with Manufacturing, Process Engineering, Quality, CSV, OT Infrastructure, Digital, equipment suppliers, OEM controls teams, and system integrators.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Science, or a related technical field.
- At least 6 years of progressive automation and controls engineering experience in pharmaceutical or biopharmaceutical manufacturing.
- Direct hands-on ownership of automation and controls systems in a cGMP manufacturing environment, including drug product aseptic or sterile manufacturing.
- Experience with ISA-95 Level 1 and Level 2 systems, PLC and/or DCS controls, SCADA/HMI, batch or sequence control, machine controls, industrial networks, communication protocols, and OT infrastructure.
- Knowledge of ISA-88, ISA-95, cGMP, GAMP 5, 21 CFR Part 11, EU GMP Annex 11, data integrity, and risk-based validation.
- Ability and willingness to travel and support on-site project execution, including periodic international travel.
Nice to have
- Experience with aseptic filling and finish equipment, isolators, or restricted-access barrier technologies.
- Experience with robotics, motion control, batch and sequence control, MES, historian platforms, and large pharmaceutical capital projects.
- Hands-on experience with Rockwell Automation, Siemens, Emerson DeltaV, OSI PI, Werum PAS-X, or comparable technologies.
- Experience with automation lifecycle management, reliability engineering, operational readiness, and maintenance strategy.
- Knowledge of Industry 4.0, Industrial Internet of Things, advanced analytics, or digital biopharmaceutical manufacturing.
Culture & Benefits
- Inclusive work environment focused on respect, diversity, and individual dignity.
- Work within Innovative Medicine on treatments and manufacturing systems that support patient care.
- Collaboration across global and multi-site engineering, manufacturing, quality, digital, and supplier organizations.
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