24.03.2026 aktualisiert

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40 % teilweise verfügbar

Manufacturing Execution System (MES) Consultant

St. Gallen, Schweiz
Nur Remote
Biological Process Engineer (University of Applied Science Frankfurt)
St. Gallen, Schweiz
Nur Remote
Biological Process Engineer (University of Applied Science Frankfurt)

Profilanlagen

CV - Ioannis Mavrosumis

Skills

BiotechnologieGood Manufacturing PracticesChange ManagementInformationssicherheitBeratungDatenintegritätDigitalisierungGentherapieIt Service ManagementSachgüterproduktionManufacturing Execution SystemsPharmazieSystemtestsVerpackung und KennzeichnungGXP
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

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2020

Sprachen

DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisseGriechischMuttersprache

Projekthistorie

MES PASX Global L2 Integration Concept

TAKEDA

Pharma und Medizintechnik

>10.000 Mitarbeiter


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

MES PASX L2 MBR Design

BBraun

Pharma und Medizintechnik

>10.000 Mitarbeiter


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

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

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

Packaging Line Integration to MES PASX

Vetter Pharma

Pharma und Medizintechnik

500-1000 Mitarbeiter


Packaging
Commercial Manufacturing
o Level 2 Integration
o DCS / MES Interface qualification (Interface)
o Support of “Pre-Test & Proof of Concept” (Interface Infrastructure)
o MBR Design Support
o Go-live support

Packaging Line Integration into MES PASX

Vetter Pharma

Pharma und Medizintechnik

500-1000 Mitarbeiter


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

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

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

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