46 минут назад
Specialist, Manufacturing (Biotech/Pharma Manufacturing)
71 721 - 97 034€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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