Basic-Profil
Profilbild
Guido Kaminski
Sofort verfügbar
Experte für OT, Cybersecurity, Data Integrity, CSV

Allgemeine Informationen

Startdatum
ASAP / ab sofort
Remote
Nicht angegeben

Berufs- und Projekthistorie

Senior Executive CSV-Analyst Global Applications - UCB Biopharma SRL Brussels

04/2025 – 11/2025

Freelancer LIFE SCIENCES

  • Computerized Systems Validation of non-Infrastructure

Systems & Platforms

  • Change Control GxP & non-GxP
  • Decommissioning of Legacy Systems
  • CAPA-Management Defects & Deviations
  • Validation Subject Matter Expert

10.2025 - today Executive Lead IT/OT-Engineer - Sartorius CellGenix GmbH Freiburg

Freelancer LIFE SCIENCES

  • Cell & Gene Therapies Competence Center Greenfield-Ramp-Up
  • Production Infrastructure Installation & Configuration
  • Cybersecurity (NIS2/IEC62433/TRBS 1115-1/ISO 27001 )
  • Building Automation & Environmental Monitoring
  • Stakeholder- and Application Management + Operational Readiness

IT-Architect - grips.bio (an ALS Flight-Service GmbH Project) Essen

Freelancer FOOD & BEVERAGE

IT-Project Director - Mylan Pharmaceuticals N.V. Central Europe

Freelancer LIFE SCIENCES

Senior IT-Consultant - Self-employed Essen

Sole Proprietor IT

Career Break

03/2023 – 12/2023

Trainings for ITSM

Senior Executive CSV/DI-Engineer - Sanofi-Aventis Deutschland GmbH Frankfurt

Freelancer LIFE SCIENCES

  • Computerized Systems Validation of Lab Equipment
  • Data Integrity Management
  • Backup/Restore & Disaster Recovery
  • SOP Authoring
  • Deliverables Contributing /Editing

Guido Kaminski

01/2023 – 03/2023

  • Oct 16th 1974 in Germany

Bullet Skills

08/2022 – 12/2022

Operational Technology Applications

  • Siemens TIA-Portal/SCADA/WinCC
  • Mettler-Toledo Lab-X
  • Aveva (OSI) PI
  • iCD LIMS|LabWare|LabVantage
  • SAP 4Hana
  • LWS Lighthouse Pharma Suite
  • Koerber PAS-X/Line Optimizer
  • Rockwell Pharmasuite
  • Emerson DeltaV/Syncade
  • PLC Engineering
  • PLC Coding Basics

Compliance

  • (c)G(A)MP(5)
  • FDA 21 CFR Part 11
  • EudraLex Vol.4
  • WHO Annex 5
  • ISA-95
  • ITIL/ISOs/Principles

ITSM/Change Control

  • OpenText SM/QALM
  • TOPdesk
  • ServiceNOW
  • TrackWise
  • Atlassian Jira/Confluence
  • Veeva (CRM/eVAL)
  • BMC Helix

Operating Systems

  • VMware
  • MS Windows Servers
  • Red Hat Linux

Project Management

  • CAPEX/OPEX
  • Waterfall
  • Agile
  • Scrum

IT-Management

  • Enterprise Systems & Network

Management

  • Asset Management
  • Software Delivery
  • SLA-Management
  • HAV-Management
  • Enterprise Backup/Restore &

Disaster Recovery

ALL MENTIONED SOFTWARE, HARDWARE AND GUIDELINES ALWAYS UP TO THE MOST RECENT RELEASE

(So could e.g. be Win NT x Server as well as Win Server 202x).

Security

  • Cisco & Sophos Firewalls● MS Security Copilot/Defender/ATP● Claroty SRA

Network/Storage

  • DELL-/EMC-SAN/HPE● DELL & Cisco Blades● Cisco/HP EAruba-Switches/Routers

Senior Executive IT/OT-Engineer - STADA AG (Norbitec GmbH) Hamburg

05/2021 – 04/2022

Freelancer LIFE SCIENCES

  • CSV-Remediation of M ES & Lab Equipment
  • Data Integrity Management
  • USP/DSP/F&F-Automation
  • FDA-Hardening
  • Audit-Proof GPO & Bloatware Administration

Lead Systems Engineer - IpTelematics GmbH Essen

08/2008 – 10/2009

Fixed Employee IT

  • Technical Project-Management Voice- & Video-Networking
  • Solution-Design, -Implementation, -Administration and -Customizing

Senior Executive IT/OT-Engineer - SKY Deutschland GmbH & Co. KG Munich

Temporary Employee BROADCASTING

  • Virtualization Operating Systems Administration
  • Virtualization Network Environment Management
  • Virtualization Hardware Maintenance
  • Virtualization Backup/Restore & Disaster Recovery
  • Virtualization Software Licensing Management

Senior IT/OT and DI -Engineer - Lonza Pharmaceuticals B.V. The Netherlands

FreFreelancer LIFE SCIENCES

  • Computerized Systems Validation of MES & Lab Equipment within Project

MODERNA VACCINE

  • Data Integrity Management
  • MES & Lab Equipment Administration
  • Buil ding Management Systems Administration
  • Environmental Monitoring

IT-Consultant/Solution Architect - Self-employed Essen

10/2004 – 08/2008

Sole Proprietor IT

  • Field focus: The Medias – Entertainment – Gastronomy and Suppliers● Key-Responsibilities: Technical Project Management - Implementation - Administration

IT-Solution Engineer - Fujitsu-Siemens Computers GmbH Düsseldorf

08/2003 – 09/2004

Fixed Employee IT

  • Technical Project-Management (Invitations to tender - Key Account)● Beta-Test of Management-Software (UNIX) - Trainer for CA Unicenter

Further Certifications

IT-Systems Engineer - Fujitsu-Siemens Computers GmbH Essen

08/2002 – 07/2003

Fixed Employee IT

  • High Availability Software-Integration● Network-Analysis - Systems-Administration

IT-Management Consultant - Fujitsu-Siemens Computers GmbH Essen

08/2001 – 07/2002

Fixed Employee IT

  • Implementation Network- and System Management Solutions
  • Heterogeneous Environments - Post Sales

Technical Sales Consultant - Siemens AG Cologne

04/2000 – 08/2001

Fixed Employee IT

  • Increasing Client-/Server-Solution Sales
  • Stabilization of Network-Business
Freitext

Service Owner - Arvato Systems GmbH (Bertelsmann AG) Gütersloh

Temporary Employee ITSM

  • Service Delivery Management for ERP, DMS and Custom Applications
  • Change Control for the German National Critical Power Grid Infrastructure
  • Knowledge Base Responsibility of Business Services and Processes
  • Incident and Service Request Dispatching
  • Operating Systems, Firewall and Proxy Management

05.2024 - 04.2025

01.2024 - 04.2024

08.2020 - 05.2021

  • Systems Infrastructure
  • Network Infrastructure
  • Data Integrity Management
  • HACCP-Compliance
  • Backup/Restore & Disaster Recovery

05.2019 - 07.2020

  • Cloud-Migration of File Servers and OT-Application Servers
  • Migration/Replacement and Validation of MES & Lab Equipment
  • Data Automation
  • Data Integrity Management● Backup/Restore & Disaster Recovery

10.2009 - 04.2019

  • Client Examples: Heinz! Magazine - Lanzdorf GmbH AUS - Feinschliff GmbH Cologne
  • Systems Infrastructure
  • Network Infrastucture
  • Collaboration Management
  • Communications Management

05.2022 - 11.2022

02.1999 - 03.2000

  • Network-Design/Design Buildings-Infrastructure
  • Design Client-/Server-Environments

Application Specialist - Siemens AG Cologne

Fixed Employee IT

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