01.10.2026 aktualisiert
100 % verfügbar
Senior Automation & OT Engineer | GMP | Cyber Security | Industry 4.0
Bad Säckingen, Deutschland
Deutschland +10
Dipl. Engineer - Automation (FH), University of Applied Sciences, Emden, Germanyinfo: Deutschland, Schweiz, Neuseeland, China, Dänemark, Finnland, Irland, Japan, Kanada, Norwegen, Singapur
Skills
AutomatisierungAutomotive Open System ArchitectureChange ControlChange ManagementElectronic Design AutomationLife Cycle EngineeringFertigungsautomatisierungPharma-EngineeringProjektablaufSIMATIC WinccBackup And RestoreProjektberatungLifecycle ManagementProject EngineeringIndustrie 4.0
Industrial Automation & OT Engineering
19 years of international experience in industrial automation, including nearly 9 years in GMP-regulated pharmaceutical manufacturing. Expertise in developing and implementing automation strategies, OT architectures, and engineering standards across complex manufacturing environments.
GxP Data Integrity & Computer System Validation (CSV)
Extensive knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, and EU GMP Annex 11. Preparation of qualification and validation documentation (URS, DQ, IQ, OQ, PQ) and support of QA compliance activities.
Cyber Security & OT Network Architecture
Development of OT network concepts and strategies, including cybersecurity measures and network hardening. Implementation of OT infrastructure solutions covering network architecture, user access management, remote access, and maintenance strategies.
Project Management & CAPEX
Project management including cost control, team lead, coordination, and CAPEX support across large-scale industrial and pharmaceutical projects.
Engineering Technology Strategy & Digitalization / Industry 4.0
Development of engineering technology roadmaps and digitalization initiatives, driving Industry 4.0 transformation across manufacturing environments.
Vertical Integration & MES
System integration of PLC with Aveva PI and MES, including integration of process equipment with OSI PI-Historian and Manufacturing Execution Systems.
Siemens Systems
Proficiency in Siemens automation systems including S7, TIA Portal, WinCC, and PCS7 for plant programming, visualization, and control.
Building Management & Alarm Management
System ownership and support for Building Management Systems (BMS), Room Monitoring Systems (RMS), Environmental Monitoring Systems (EMS), and Alarm Management including escalation and monitoring.
Corrective & Preventive Actions (CAPA) & Change Management
Coordination of Change Controls, Deviations, CAPAs, and Quality Events using Agile ACC, 1QEM, and ServiceNow. Active involvement in quality events, deviations, and corrective actions.
Novartis Standards & Enterprise Tools
Practical experience with Novartis-specific standards and tools including SAP, COMOS, ACC-Agile, 1QEM, ESOPS-D2, and ServiceNow.
ABB & Honeywell Systems
Experience with ABB systems (800xA, Teleperm XS, BMS) and Honeywell systems (RMS/BMS) in industrial and pharmaceutical environments.
Acceptance Testing (FAT / SAT)
Planning and execution of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for automation and control systems.
19 years of international experience in industrial automation, including nearly 9 years in GMP-regulated pharmaceutical manufacturing. Expertise in developing and implementing automation strategies, OT architectures, and engineering standards across complex manufacturing environments.
GxP Data Integrity & Computer System Validation (CSV)
Extensive knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, and EU GMP Annex 11. Preparation of qualification and validation documentation (URS, DQ, IQ, OQ, PQ) and support of QA compliance activities.
Cyber Security & OT Network Architecture
Development of OT network concepts and strategies, including cybersecurity measures and network hardening. Implementation of OT infrastructure solutions covering network architecture, user access management, remote access, and maintenance strategies.
Project Management & CAPEX
Project management including cost control, team lead, coordination, and CAPEX support across large-scale industrial and pharmaceutical projects.
Engineering Technology Strategy & Digitalization / Industry 4.0
Development of engineering technology roadmaps and digitalization initiatives, driving Industry 4.0 transformation across manufacturing environments.
Vertical Integration & MES
System integration of PLC with Aveva PI and MES, including integration of process equipment with OSI PI-Historian and Manufacturing Execution Systems.
Siemens Systems
Proficiency in Siemens automation systems including S7, TIA Portal, WinCC, and PCS7 for plant programming, visualization, and control.
Building Management & Alarm Management
System ownership and support for Building Management Systems (BMS), Room Monitoring Systems (RMS), Environmental Monitoring Systems (EMS), and Alarm Management including escalation and monitoring.
Corrective & Preventive Actions (CAPA) & Change Management
Coordination of Change Controls, Deviations, CAPAs, and Quality Events using Agile ACC, 1QEM, and ServiceNow. Active involvement in quality events, deviations, and corrective actions.
Novartis Standards & Enterprise Tools
Practical experience with Novartis-specific standards and tools including SAP, COMOS, ACC-Agile, 1QEM, ESOPS-D2, and ServiceNow.
ABB & Honeywell Systems
Experience with ABB systems (800xA, Teleperm XS, BMS) and Honeywell systems (RMS/BMS) in industrial and pharmaceutical environments.
Acceptance Testing (FAT / SAT)
Planning and execution of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for automation and control systems.
Erfahrung
Berufserfahrung0 - 5 Jahre
Freelancer seit2026
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Planned and executed modifications to the plant Instrumentation & Control (I&C) systems through various engineering projects. Initiated and coordinated system modifications and maintenance activities at the system level. Coordinated with regulatory authorities, engineering partners, and suppliers on technical matters. Prepared technical specifications and managed procurement of replacement equipment. Key projects: Project Lead for Radioactive Waste Solidification System, Annual Plant Outage (Refueling and Maintenance Shutdown), System Owner for Safety-Critical Priority 1 I&C Subsystems.
Led the Building Management System (BMS) modernization project. Developed Operational Technology (OT) network architecture and infrastructure concepts. Performed automation requirements analysis for OT and BMS projects. Prepared User Requirement Specifications (URS) for OT network solutions. Ensured compliance with GMP, cybersecurity, and corporate engineering standards. Key projects: OT Network Architecture & Infrastructure Strategy, Infrastructure Technology Roadmap, Future GMP & Compliance Readiness.
Led automation projects and CAPEX activities for pharmaceutical manufacturing and infrastructure systems. Developed and implemented OT infrastructure solutions including network architecture, backup and restore, user access management, remote access, and maintenance strategies. Supported BMS, RMS, and EMS systems. Acted as SME during internal and external GMP audits. Supported QA compliance and CSV activities in accordance with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11. Coordinated Change Controls, Deviations, CAPAs, and Quality Events. Key projects: Serialization & Aggregation, Data Integrity (TOPAZ), Vertical Integration, Cyber Security (CARBON), New Manufacturing Facility Commissioning, SOPS / ServiceNow Harmonization.