Spezialist Qualifizierung Pharmazeutischer Anlagen (w/m/d)
Core
Qualification of pharmaceutical equipment, processes, and production lines to ensure quality standards and patient safety.
Role type
Specialist in Pharmaceutical Equipment Qualification
Builds
Pharmaceutical production equipment and processes for patient therapies
Domain
Biopharmaceuticals / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical or natural science education, Quality management, Project management, Risk assessment, Documentation creation, Regulatory knowledge
Preferred skills
Experience in pharmaceutical/chemical industry, German and English fluency
Technologies
GMP, Validation protocols, Risk assessment tools
Responsibilities
Plan and coordinate qualification activities for production equipment and sterilization processes, Create and review qualification documentation and test protocols, Conduct operational qualification activities like temperature studies, Participate in interdisciplinary project teams for equipment implementation and optimization, Support internal and external audits
Seniority
Entry to Mid-level, hands-on IC