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3 дня назад

Manufacturing System Engineer - Testing Machine System Owner (Automation)

105 363 - 142 549$
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

Текст:
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TL;DR
Manufacturing System Engineer - Testing Machine System Owner (Automation): Designing, integrating, and maintaining automation systems for quality-critical testing equipment at an advanced pharmaceutical assembly and packaging plant with an accent on PLCs, HMIs, validation, and data integrity. Focus on leading system lifecycle management, troubleshooting automation issues, supporting FDA and GMP compliance, and driving performance improvements through data analysis.

Location: New Albany, Ohio, United States; onsite role with an administrative schedule of 8:00 a.m.–5:00 p.m., Monday–Friday.

Annual salary: USD 105,362.60–142,549.40.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Own quality-critical testing automation systems and ensure reliable, efficient, compliant operation.
  • Design, configure, optimize, and maintain PLCs, HMIs, control strategies, instruments, and related automation components.
  • Integrate new automation technologies and instruments, analyze performance data, and lead continuous improvement initiatives.
  • Provide technical troubleshooting and lifecycle support, including upgrades, patching, preventive maintenance, root cause analysis, and corrective actions.
  • Support FDA, GMP, internal audits, inspections, validation activities, and data-integrity requirements in partnership with Quality and Regulatory Affairs.
  • Lead automation projects, develop technical training, and collaborate with engineering, maintenance, quality, and cross-site system-owner teams.

Requirements

  • Master’s degree, or a bachelor’s degree plus 2 years of automation experience, or an associate’s degree plus 6 years of automation experience, or a high school diploma/GED plus 8 years of automation experience in pharmaceutical, medical-device, or biotechnology industries.
  • Experience with programming, design, installation, validation, and lifecycle management of manufacturing controls, automation, and field instrumentation.
  • Knowledge of pharmaceutical or biotechnology processes, particularly final drug product operations, data integrity, and security.
  • Ability to apply GAMP and GMP principles and execute validation protocols for new equipment installations.
  • Strong project management, problem-solving, technical writing, communication, presentation, collaboration, and facilitation skills.
  • Work must be performed at the New Albany, Ohio site.

Nice to have

  • Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering.
  • Exposure to machine vision, serialization, robotics, Siemens, and Rockwell software platforms.
  • Understanding of Operational Excellence and Lean Transformation in automation and engineering.

Culture & Benefits

  • Collaborative, inclusive, innovative, and science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions.
  • Discretionary annual bonus, stock-based long-term incentives, and award-winning time-off plans.
  • Career development opportunities and support for professional and personal well-being.

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