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2 дня назад

Manufacturing Training Specialist Manufacturing Support (Biotechnology)

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 Training Specialist Manufacturing Support (Biotechnology): Developing and executing training and qualification programs for the ANC-1 and ANC-2 drug-substance manufacturing organizations with an accent on workforce readiness, compliance, and startup execution. Focus on governing readiness metrics, leading LMS migration and training-related CAPAs, and solving qualification and operational readiness risks in a 24/7 manufacturing environment.

Location: Holly Springs, North Carolina, United States; onsite role with significant manufacturing floor presence in a 24/7 manufacturing environment

Company

hirify.global is a biotechnology company developing and manufacturing medicines for patients worldwide.

What you will do

  • Develop and execute the manufacturing training strategy for the ANC-1 and ANC-2 organizations.
  • Create and maintain role-based qualification pathways, readiness governance tools, metrics, and reporting.
  • Identify and mitigate training, staffing, qualification, procedure, and startup-readiness risks.
  • Lead Manufacturing Fundamentals Training, technical training programs, and the 2027 Learning Management System migration.
  • Own training-related corrective and preventive actions, assess training effectiveness, and lead continuous improvement initiatives.
  • Coach manufacturing personnel and frontline leaders while partnering with Manufacturing, Quality, Engineering, Validation, Supply Chain, HR, and Continuous Improvement teams.

Requirements

  • Doctorate degree, or a master's degree in chemistry, biology, or engineering with 3 years of biotechnology operations experience.
  • Bachelor's degree with 5 years of biotechnology operations experience, or an associate's degree with 10 years of experience.
  • High school diploma or GED with 12 years of biotechnology operations experience.
  • Experience with training development and facilitation, standard operating procedures, and deviation or CAPA systems.
  • Strong knowledge of Learning Management Systems, project management, communication, and stakeholder relationship-building.
  • Ability to work onsite with regular manufacturing floor presence in Holly Springs, North Carolina.

Culture & Benefits

  • Work in a new drug-substance manufacturing facility combining disposable technologies, stainless-steel equipment, and industry 4.0 capabilities.
  • Collaborate in a cross-functional environment focused on safety, quality, delivery, productivity, and operational excellence.
  • Support sustainability initiatives designed to reduce carbon emissions and waste.
  • Participate in a mission-driven biotechnology organization serving patients worldwide.

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