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46 минут назад

Specialist, Manufacturing (Biotech/Pharma Manufacturing)

71 721 - 97 034
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Ireland
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
Specialist, Manufacturing (Biotech/Pharma Manufacturing): Leading investigations into fill/finish, inspection, and packaging deviations with an accent on root cause analysis, CAPA development, product impact assessment, and compliant technical documentation. Focus on coordinating complex cross-functional investigations, presenting findings to regulators and auditors, and driving improvements to investigation processes.

Location: Dublin, Ireland

Salary: €71,721.30–€97,034.70 per year

Company

hirify.global operates in biotech and pharmaceutical manufacturing.

What you will do

  • Lead deviation investigations for fill/finish, inspection, and packaging operations.
  • Establish investigation teams, lead root cause analysis, develop CAPAs, and complete product impact assessments.
  • Write clear, concise, and compliant technical investigation documentation.
  • Coordinate cross-functional teams and manage investigations from initiation through completion.
  • Present complex investigations to regulatory inspectors, internal auditors, leadership, and other stakeholder groups.
  • Drive improvements to the investigation process and apply structured problem-solving methods.

Requirements

  • Bachelor’s degree in science or engineering with 5+ years of directly related experience, or an associate’s degree with 8+ years of experience, in biotech/pharma manufacturing or manufacturing support; alternatively, 10+ years of directly related manufacturing experience.
  • Detailed technical understanding of fill/finish operations.
  • Experience with compliance, root cause analysis, critical thinking, project management, and quality systems.
  • Experience leading complex investigations and participating in or leading cross-functional teams.
  • Experience presenting to inspectors during regulatory inspections and internal audits.
  • Excellent technical writing, presentation, communication, and collaboration skills.

Culture & Benefits

  • Work in a fast-paced manufacturing environment with multiple competing priorities.
  • Apply a continuous improvement mindset to quality and compliance processes.
  • Collaborate across technical, manufacturing, quality, and management functions.
  • Use structured problem-solving while navigating ambiguity and organizational change.

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