Profilbild von Anonymes Profil, Manufacturing Execution System (MES) Consultant
nicht verfügbar bis 31.08.2024

Letztes Update: 19.09.2023

Manufacturing Execution System (MES) Consultant

Firma: WERECON AG
Abschluss: Biological Process Engineer (University of Applied Science Frankfurt)
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse) | griechisch (Muttersprache)

Dateianlagen

Ioannis Mavrosumis CV V202011.pdf

Skills

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, MSI)
• Biotech production process
• Pharma production process
• Packaging process
• Filling process
• Cell and Gene therapy
• Change Management
• Documentation and Qualification
• Digitalization

Projekthistorie

01/2020 - bis jetzt
MES Business Analyst
Novartis (Pharma und Medizintechnik, >10.000 Mitarbeiter)

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

06/2018 - bis jetzt
MES Business Analyst
Novartis (Pharma und Medizintechnik, >10.000 Mitarbeiter)

Biotech
Commercial Manufacturing
o Level 2 Integration
o DCS / MES Interface qualification (PCS MBR Elements, Interface)
o Support of “Pre-Test & Proof of Concept” (Interface Infrastructure)
o Basic System Training
o MBR Design Support
o Go-live support

01/2014 - 12/2019
MES Business Analyst (100%)
Novartis (Pharma und Medizintechnik, >10.000 Mitarbeiter)

Pharma, Solids, Liquids (New Solid Launch Facility)
Commercial Manufacturing, Packaging, Fill & Finish
o MES System Training
o Fit-Gap- Analysis
o IQ, OQ, PQ – Documentation Creation and Execution
o FAT Preparation / Execution (Process Equipment, MES System)
o SCADA / MES Interface Creation and Qualification
o Proof of concept (Level 2 Interface Infrastructure)
o Data exchange concept definition between MES and Process Equipment
o FS, SDS – Documentation Creation
o Significant contribution in Standardized Recipe Management (SRM) Development and PI Historian usage as Line Management System
o Go-live support
o On Site Support during Development and Qualification Phase
o Qualification / Test support
o Scale Integration to MES

01/2013 - 12/2013
MES Business Analyst (100%)
Novartis (Pharma und Medizintechnik, >10.000 Mitarbeiter)

Biotech
Commercial Manufacturing, Packaging
• Scope of work
o PAS-X 3.1.5 System Installation and Configuration
o DCS / MES Interface creation
o Support of “Pre-Test & Proof of Concept” (Interface Infrastructure)
o PCS MBR Elements (executive) creation
o WMS Management
o Basic System Training
o MBR support
o Creation of Functional Specifications
o Creation of User Requirement Specifications

Reisebereitschaft

Nur Remote verfügbar
Profilbild von Anonymes Profil, Manufacturing Execution System (MES) Consultant Manufacturing Execution System (MES) Consultant
Registrieren