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8 дней назад

Clean Utilities Sr Engineer (Biopharmaceutical)

115 495 - 156 257$
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
Clean Utilities Sr Engineer (Biopharmaceutical): Designing, building, commissioning, and qualifying clean and plant utility systems for biopharmaceutical drug substance production with an accent on GMP compliance, system ownership, and equipment reliability. Focus on troubleshooting utility systems, leading root cause analysis and corrective actions, implementing predictive maintenance, and supporting capital projects and new product introductions.

Location: Holly Springs, North Carolina, United States; onsite role supporting 24/7 operations with occasional after-hours coverage

Annual salary: $115,494.60–$156,257.40 USD

Company

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

What you will do

  • Own clean and plant utility systems and equipment supporting site operations.
  • Support the design, construction, startup, commissioning, and qualification of new or modified systems.
  • Lead engineering improvements, upgrades, equipment modifications, and capital project activities.
  • Develop maintenance programs, manage spare-parts availability, and support maintenance execution.
  • Monitor system performance, troubleshoot production issues, and lead root cause investigations and corrective/preventive actions.
  • Support new product and technology introductions, engineering runs, predictive maintenance, and deviation investigations.

Requirements

  • High school diploma/GED with 10 years of engineering or maintenance experience, associate degree with 8 years, bachelor’s degree with 4 years, master’s degree with 2 years, or a doctorate.
  • Bachelor’s degree in chemical, mechanical, or electrical engineering is preferred.
  • Experience with biopharmaceutical utility systems, including pharmaceutical water, clean steam, clean air, chillers, cooling towers, boilers, and air compressors.
  • Experience with control systems, GMP operations, qualification and validation, change control, deviations, and corrective/preventive actions.
  • Knowledge of capital project execution, system modifications, safety requirements, and regulated environments such as cGMP, OSHA, and EPA.
  • Ability to support 24/7 operations, occasional after-hours engineering coverage, and domestic or international travel.

Nice to have

  • Experience in biopharmaceutical operations or manufacturing.
  • Experience with data analytics, statistical process control, Six Sigma, predictive maintenance, and root cause analysis.
  • Strong technical writing, communication, presentation, facilitation, leadership, and teamwork skills.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plan with company contributions.
  • Annual bonus opportunity and stock-based long-term incentives.
  • Paid time off and career development opportunities.

Hiring process

  • Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
  • Visa sponsorship is not guaranteed.

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