Produkt - und Validierungsspezialist (m/w/d)
Core
End-to-End responsibility for specific solid-dosage pharmaceutical products (tablets, granulates, implants) including production process optimization, validation, and regulatory documentation.
Role type
Senior Process Validation & Product Specialist (Pharmaceutical Manufacturing)
Builds
Solid-dosage drug products for veterinary and human use, primarily for export markets
Domain
Pharmaceutical manufacturing / Veterinary medicine / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, GMP compliance, Change control (CAPA), Regulatory documentation, Experimental design (DoE), Supplier qualification, Equipment selection, Project management, Statistical analysis
Preferred skills
Experience with solid-dosage forms, Process optimization expertise
Technologies
Microsoft Office, Statistical analysis tools
Responsibilities
Lead projects as product expert, Conduct product transfers and test batches, Evaluate alternative API suppliers and production technologies, Serve as contact for regulatory inspections (FDA, AGES), Manage change requests and events
Seniority
Mid-to-Senior, hands-on IC
