Manufacturing Science and Technology Engineer (m/w/d)
Core
Lead and execute projects for biopharmaceutical clients, focusing on process transfer, validation, optimization, and lifecycle management to ensure GMP-compliant production.
Role type
Senior Manufacturing Science and Technology Engineer (Biopharma)
Builds
Biopharmaceutical production processes (Drug Substance & Drug Product) and validated manufacturing systems
Domain
Biopharmaceuticals / Process Engineering / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Process development, Process validation, Process characterization, Statistical process control, Project management, Risk analysis, GMP compliance, Regulatory knowledge (EMA/FDA/ICH), English, German
Preferred skills
Statistical software (Minitab, JMP), Process design, Production organization support
Technologies
Minitab, JMP
Responsibilities
Lead cross-functional international projects, Develop and optimize biopharmaceutical production processes, Create study plans and reports, Conduct risk analysis for production and cleaning processes, Manage GMP deviations, Advise clients on regulatory requirements, Provide technical support for quality assurance and production planning
Seniority
Mid-Senior, hands-on IC
