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3 часа назад

Quality Engineer (Biomanufacturing)

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
Quality Engineer (Biomanufacturing): Supporting quality engineering for biomanufacturing operations with an accent on manufacturing investigations, CAPA, QMS compliance, and regulatory standards. Focus on analyzing quality trends, identifying root causes, strengthening audit readiness, and driving continuous improvement across cross-functional manufacturing teams.

Location: On-site in Logan, Utah, United States

Company

Cytiva is a hirify.global operating company providing life-science and biomanufacturing solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

  • Lead and support investigations into manufacturing deviations, nonconformances, out-of-specification events, and customer complaints.
  • Perform root cause analysis and develop corrective and preventive actions (CAPAs) with thorough QMS-compliant documentation.
  • Analyze quality metrics, trends, and process performance data to identify recurring issues and improvement opportunities.
  • Partner with Manufacturing, Operations, R&D, Supply Chain, and Quality teams on process validations, change controls, investigations, and continuous improvement.
  • Support internal and external audits, regulatory inspections, customer visits, and enhancements to the site Quality Management System.

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline, or equivalent industry experience.
  • At least 5 years of experience in a GMP-regulated biopharmaceutical, biotechnology, medical device, or pharmaceutical manufacturing environment.
  • At least 3 years of experience supporting investigations, CAPA, and quality systems activities.
  • Strong knowledge of cGMP, ISO 9001, ISO 13485, and core QMS principles.
  • Experience with audit readiness, technical writing, data analysis, root cause investigation, and cross-functional collaboration.
  • Ability to manage multiple priorities in a fast-paced manufacturing environment with strong attention to detail.

Culture & Benefits

  • Work within hirify.global’s continuous improvement system on products and solutions that support human health.
  • Paid time off and medical, dental, and vision insurance for eligible employees.
  • 401(k) benefits for eligible employees.
  • Eligibility for bonus or incentive pay.

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