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9 дней назад

Process Engineer II - Equipment Engineering (Biotechnology)

99 705 - 129 030$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Process Engineer II - Equipment Engineering (Biotechnology): Supporting the lifecycle, reliability, qualification, and compliance of manufacturing, laboratory, and facility equipment used in cell therapy production with an accent on GMP operations, troubleshooting, and cross-functional equipment ownership. Focus on analyzing equipment failures, implementing CAPAs and change controls, improving maintenance strategies, and supporting commissioning and qualification of new systems.

Location: Frederick, Maryland, United States; onsite at a cell therapy manufacturing facility

Salary: $99,705–$129,030 annually, plus potential discretionary bonus, stock-based incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

  • Support the operation and lifecycle management of manufacturing, laboratory, and facility equipment.
  • Own equipment assets in the Enterprise Asset Management System and support repairs, maintenance, investigations, and troubleshooting.
  • Analyze equipment failures, maintenance records, and performance trends to identify reliability improvements.
  • Support CAPAs, change controls, engineering assessments, technical reports, and regulatory inspections.
  • Assist with specification, procurement, installation, commissioning, and qualification of new equipment.
  • Collaborate with Manufacturing, Quality, Validation, Maintenance, Supply Chain, and vendors on reliability, compliance, capacity, safety, and operational efficiency.

Requirements

  • Bachelor’s degree in Engineering, such as Chemical Engineering, Mechanical Engineering, Bioengineering, or a similar discipline.
  • 3–5 years of engineering experience in biotechnology, pharmaceutical, medical device, or another regulated industry.
  • Strong analytical, problem-solving, written, and verbal communication skills.
  • Ability to work effectively in cross-functional teams.
  • Experience with equipment maintenance, troubleshooting, or validation activities.
  • Experience with cell therapy manufacturing equipment, automated manufacturing platforms, laboratory instrumentation, cryogenic storage, or filter integrity testing systems is relevant.

Nice to have

  • Familiarity with GMP manufacturing environments.
  • Experience with equipment reliability initiatives, maintenance optimization, or spare parts strategies.

Culture & Benefits

  • Work in a state-of-the-art cell therapy manufacturing facility focused on cancer treatment development.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
  • Paid time off and potential annual bonus and stock-based long-term incentives may be available.
  • Inclusive workplace with emphasis on collaboration, development, empowerment, safety, quality, and compliance.

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