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3 дня назад

Manufacturing Associate I (Sterile Injectables)

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
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TL;DR
Manufacturing Associate I (Sterile Injectables): Performing aseptic and non-aseptic manufacturing operations for sterile injectable products with an accent on equipment preparation, compounding, formulation, filtration, and fill-finish activities. Focus on executing GMP procedures, maintaining aseptic technique, completing batch documentation, and supporting investigations, validation, and cross-functional manufacturing activities.

Location: York, United States; manufacturing work in a GMP facility with extended shifts and a variable schedule when required.

Company

hirify.global provides pharmaceutical development and manufacturing services through BioTechnique, a sterile injectable full-service CDMO specializing in formulation, compounding, fill-finish, and lyophilization.

What you will do

  • Perform routine and critical aseptic and non-aseptic manufacturing operations for sterile injectable products.
  • Prepare equipment for production, including CIP and SIP operations.
  • Execute compounding, filtration, formulation, filling, and primary processing activities according to manufacturing instructions and SOPs.
  • Maintain aseptic gowning certification, perform room sanitization, and follow proper aseptic techniques.
  • Complete batch records, logbooks, forms, and other production documentation in accordance with Good Documentation Practices.
  • Identify and document deviations, participate in investigations, support commissioning and validation, and collaborate with engineering, warehouse, and facilities teams.

Requirements

  • High school diploma and 1–2 years of experience in a mechanically based or similar role.
  • 1–2 years of manufacturing experience in an FDA-regulated pharmaceutical facility preferred.
  • Experience with controlled documents and sterile injectable drugs preferred.
  • Familiarity with formulation, filling, primary packaging, aseptic processing, and aseptic techniques preferred.
  • Ability to follow written procedures, complete multiple floor activities, and maintain strong attention to detail and quality.
  • Strong communication, analytical, organizational, prioritization, and mechanical aptitude skills; experience with Microsoft Office and Excel.

Culture & Benefits

  • Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
  • Employee assistance programs, basic life insurance, short- and long-term disability coverage, and other insurance options.
  • 401(k) plan with matching, PTO, sick time, and paid holidays.
  • Education assistance, pet insurance, fitness benefits, and financial discounts.
  • Coaching and professional development opportunities in a multicultural organization.

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