Process Engineer (m/w/d) am Standort Mannheim *2 Jahre befristet*
Core
Ensuring efficiency and validity of complex production processes in a modern GMP environment for sterile drug product manufacturing.
Role type
Process Engineer (Sterile Drug Product Manufacturing)
Builds
Sterile drug products and packaging solutions
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Process optimization, Validation & Qualification, Root Cause Analysis (RCA), GMP compliance, Project management, Data integrity, Change management, Technical troubleshooting
Preferred skills
Lean-Six-Sigma training, Matrix structure experience
Technologies
GMP documentation systems, RCA methodologies (5-Why, Ishikawa)
Responsibilities
Prioritize and organize validation/requalification activities for equipment; Lead efficiency improvement projects and product transfers; Manage deviations and drive CAPAs; Coordinate interfaces between Production, Maintenance, Quality, and IT; Create and update GMP documents (SOPs, risk assessments) in German and English.
Seniority
Mid-level, hands-on IC
