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11 часов назад

Manufacturing Technician IV, Lead (Biomanufacturing)

26 - 41$
Формат работы
onsite
Тип работы
fulltime
Грейд
lead
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 Technician IV, Lead (Biomanufacturing): Leading complex packaging-floor operations in a cGMP-regulated manufacturing environment with an accent on equipment operation, GMP documentation, validation, and continuous improvement. Focus on resolving production issues, training technicians, reviewing batch records, and coordinating daily activities during 12-hour night shifts.

Location: Blue Ash, Ohio, United States; onsite production-floor role

Salary: $26.00–$40.50 per hour

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

  • Lead and monitor complex packaging operations, including equipment start-up, operation, manual packaging, and line clearances.
  • Manage inventory control and reconciliation using SAP and WES.
  • Execute equipment qualification and process validation protocols.
  • Complete and review advanced GMP documentation, batch records, SOPs, and related process documents.
  • Support lean manufacturing, 5S, problem-solving, continuous improvement, and daily Tier 0 meetings.
  • Provide technical guidance and on-the-job training to production and mechanical technicians while collaborating with management and engineers.

Requirements

  • Significant experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing; 4+ years is preferred.
  • Advanced knowledge of cGMP requirements, quality systems, deviations, change control, and data integrity.
  • Experience reviewing critical GMP documentation and batch records.
  • Ability to independently resolve complex production issues, prioritize daily work, and make decisions under pressure.
  • Ability to read, write, speak, and understand English for technical cross-functional communication.
  • Ability to work 12-hour night shifts on a 2/2/3 schedule from 6:00 p.m. to 6:30 a.m., perform physically demanding work, use PPE, and pass an onboarding eye exam.

Nice to have

  • High school or vocational school graduation, or equivalent.
  • Prior experience as a subject-matter resource or production-floor trainer.
  • Lean manufacturing experience.
  • Working knowledge of Microsoft applications, SAP, Veeva Vault, or generative AI language tools such as Claude.

Culture & Benefits

  • Annual cash bonus program and 401(k) plan with company match.
  • Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
  • Paid vacation, paid holidays, and other paid leaves of absence.
  • Tuition reimbursement and caregiving support.
  • Visa and work-authorization sponsorship or support is not available.

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