Betriebsingenieur (m/w/d) in der Pharmaproduktion
Core
Ensuring technical availability, continuous optimization, and safe GMP/EHS-compliant operation of pharmaceutical production plants for oncology therapies.
Role type
Senior IC plant operations engineer (pharmaceutical manufacturing)
Builds
Sterile injectable drugs (oncology therapeutics) and delivery systems
Domain
Pharmaceutical manufacturing / Oncology
Required skills
GMP compliance, EHS compliance, maintenance planning, root cause analysis, Lean/Six Sigma, project management, change control, CAPA implementation, energy management, technical training
Preferred skills
Aseptic manufacturing knowledge, ERP systems proficiency
Technologies
Maintenance Management Systems, ERP systems, MS Office
Responsibilities
Maintain GMP/EHS-compliant operations and asset management plans; Coordinate internal/external service providers and spare parts; Plan and adhere to maintenance budgets; Solve technical problems and analyze deviations using Lean/Six Sigma; Execute technical plant modifications and change controls; Create GMP-compliant project and qualification documentation; Conduct qualification measures and implement CAPAs; Support site-wide energy management; Provide technical support and training; On-call availability for technical issues