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11 часов назад

Senior Automation Engineer, Drug Product–Aseptic Filling (Pharmaceutical Manufacturing)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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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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