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4 дня назад

Manufacturing Associate I (Biotech)

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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Описание вакансии

Текст:
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TL;DR
Manufacturing Associate I (Biotech): Performing sterile injectable manufacturing operations for a full-service CDMO with an accent on aseptic and non-aseptic filling, equipment preparation, cleaning, dissolution, and formulation. Focus on executing GMP manufacturing instructions, maintaining controlled environments, completing batch documentation, and investigating process deviations across variable production shifts.

Location: York, United States; onsite. Temporary W-2 position through January 29, 2027, with potential extension to a permanent full-time position. Candidates must be available for variable shifts, including weekdays, evenings, weekends, and rotating 7-day schedules.

Company

BioTechnique, part of hirify.global, is a sterile injectable full-service contract development and manufacturing organization providing formulation, compounding, fill-finish, and lyophilization services from IND applications through commercial production.

What you will do

  • Perform routine and critical aseptic and non-aseptic filling, compounding, filtration, formulation, and terminal sterilization operations.
  • Prepare production equipment using CIP and SIP operations and complete cleaning and room sanitization activities.
  • Execute manufacturing instructions, SOPs, and GMP/ISO-compliant processing steps.
  • Complete production documentation, logbooks, forms, and batch records in accordance with Good Documentation Practices.
  • Identify, escalate, and document deviations; participate in investigations and support new manufacturing processes in the GMP facility.
  • Support commissioning, validation, engineering, warehouse, and facilities activities as assigned.

Requirements

  • High school diploma and 1–2 years of experience in a mechanically based or similar role.
  • Experience in professional manufacturing, preferably in an FDA-regulated pharmaceutical facility.
  • Familiarity with sterile injectable drugs, formulation, filling, primary packaging, aseptic processing, and aseptic techniques.
  • Ability to maintain aseptic gowning certification and follow written procedures and verbal instructions precisely.
  • Experience with controlled documents and MS Office/Excel tools.
  • Strong communication, analytical, organizational, mechanical, and prioritization skills with a commitment to quality and attention to detail.

Culture & Benefits

  • Temporary W-2 employment with medical and sick time benefits.
  • Overtime eligibility based on production demands.
  • Coaching and professional development opportunities.
  • Work alongside a multicultural team supporting pharmaceutical manufacturing operations.

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