26.08.2025 aktualisiert
nicht verfügbar
Manufacturing Execution System (MES) Consultant
St. Gallen, Schweiz Biological Process Engineer (University of Applied Science Frankfurt)
Skills
MESMES ConsultantMES ConsultingMES ImplementationMES SolutioningDCS & SCADAPCS7CSVComputer System ValidationWerumWerum Pas-XWerumWerum PASKörberPI Historian
Implementation of Manufacturing Execution Systems (MES)
• MBR Consulting, Design, Review, Training
• Computer System Validation (CSV)
• Good Manufacturing Practice (GMP/GxP/GAMP5)
• Data Integrity
• IT Service Management
• IT Security
• Level 2 Integration (OPC, HISTORIAN, SAIL, MSI)
• Biotech production process
• Pharma production process
• Packaging process
• Filling process
• Cell and Gene therapy
• Change Management
• Documentation and Qualification
• Digitalization
• MBR Consulting, Design, Review, Training
• Computer System Validation (CSV)
• Good Manufacturing Practice (GMP/GxP/GAMP5)
• Data Integrity
• IT Service Management
• IT Security
• Level 2 Integration (OPC, HISTORIAN, SAIL, MSI)
• Biotech production process
• Pharma production process
• Packaging process
• Filling process
• Cell and Gene therapy
• Change Management
• Documentation and Qualification
• Digitalization
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisseGriechischMuttersprache
Projekthistorie
Biotech / Pharma
Commercial Manufacturing
o Level 2 Integration
o DCS / MES / Historian / SAIL Interface Concept Creation
o Support of “Pre-Test & Proof of Concept” (Interface Infrastructure)
o MBR Design Support
Filling
Commercial Manufacturing
o Level 2 Integration
o DCS / MES L2 MBR Design (PCS MBR Elements, MSI, Interface)
o Support of “Pre-Test & Proof of Concept” (Interface Infrastructure)
o MBR Design Support
o Go-live support
Cell and Gene
Commercial Manufacturing
o MES System Training
o Fit-Gap- Analysis
o Infrastructure
o IQ, OQ, PQ – Documentation Creation and Execution
o SCADA / MES Interface Creation and Qualification
o Data exchange concept definition between MES and Process Equipment
o FS, SDS – Documentation Creation
o Go-live support
o Qualification / Test support
o Scale Integration to MES
o Level 2 Integration
Commercial Manufacturing
o MES System Training
o Fit-Gap- Analysis
o Infrastructure
o IQ, OQ, PQ – Documentation Creation and Execution
o SCADA / MES Interface Creation and Qualification
o Data exchange concept definition between MES and Process Equipment
o FS, SDS – Documentation Creation
o Go-live support
o Qualification / Test support
o Scale Integration to MES
o Level 2 Integration