Process Engineer (m/w/d) am Standort Mannheim *2 Jahre befristet*
Core
Ensuring efficiency and validity of complex production processes in sterile drug product manufacturing (SDPM) and packaging within a GMP environment.
Role type
Process Engineer (Sterile Drug Product Manufacturing)
Builds
Sterile drug products and pharmaceutical packaging
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Process engineering, Qualification & Validation, Root Cause Analysis (RCA), Lean methodology, GMP compliance, Project management, Data integrity
Preferred skills
Lean Six Sigma, Matrix structures
Technologies
GSP, DMS, SOPs
Responsibilities
Prioritize and organize validation/requalification activities; Lead efficiency improvement projects (KVP) and product transfers; Support new investments and technology introductions; Manage deviations and lead CAPAs; Act as SPOC for GSP changes and coordinate cross-functional workflows; Create and update GMP documentation (SOPs, risk analyses).
Seniority
Mid-level, hands-on IC
