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1 день назад

Microbiologist III - 2nd Shift (Pharmaceutical Microbiology)

44 - 48$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Switzerland
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
Microbiologist III - 2nd Shift (Pharmaceutical Microbiology): Supporting sterile pharmaceutical manufacturing through microbiological testing, method validation, contamination control investigations, and technical documentation with an accent on aseptic processing, environmental monitoring, and antimicrobial effectiveness testing. Focus on leading OOT/OOS and deviation investigations, analyzing microbiological trends, supporting regulatory inspections, and mentoring microbiologists on the second shift.

Location: Irvine, California, United States; onsite, 2nd shift from 2:00 PM to 10:30 PM, Monday through Friday

Target pay range: $44–$48 per hour plus a 10% shift differential

Company

hirify.global is a global pharmaceutical contract development and manufacturing organization founded in Switzerland, with 16 sites across three continents and more than 4,200 employees.

What you will do

  • Perform microbiological testing of environmental monitoring samples, utilities, raw materials, in-process samples, and finished drug products.
  • Provide microbiology support for sterile and aseptic manufacturing operations.
  • Execute antimicrobial effectiveness testing and microbiological method validation and qualification studies.
  • Lead OOT, OOS, deviation, and contamination control investigations, including data analysis and trend evaluation.
  • Author and review protocols, technical reports, investigations, and scientific documentation.
  • Support product introductions, process improvements, technology transfers, regulatory inspections, and mentoring of microbiologists.

Requirements

  • Bachelor’s degree in Microbiology or a closely related scientific discipline; an advanced degree is preferred.
  • 8–10+ years of pharmaceutical microbiology experience supporting sterile manufacturing operations.
  • Experience with microbiological method validation and qualification, aseptic manufacturing support, and Antimicrobial Effectiveness Testing.
  • Experience leading OOT, OOS, deviation, and microbiology investigations.
  • Strong knowledge of aseptic processing, contamination control, environmental monitoring, and cGMP requirements.
  • Strong technical writing skills, including protocols, reports, investigations, and scientific documentation.

Nice to have

  • Experience in a pharmaceutical CDMO environment, regulatory inspections, or customer audits.
  • Familiarity with USP microbiology requirements.
  • Experience with LIMS and electronic laboratory systems.
  • Experience mentoring or providing technical guidance to microbiologists.

Culture & Benefits

  • Hands-on laboratory work with opportunities to develop technical and leadership expertise.
  • Medical, dental, and vision coverage.
  • Flexible Spending Account and HSA options.
  • Life insurance, short- and long-term disability coverage, pet insurance, and 401(k).
  • Work in a collaborative pharmaceutical CDMO environment focused on safety, quality, sustainability, and patient impact.

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