Industries & Project Experience

Over 25 years of experience in software development for regulated and technically demanding environments.

From BioPharma and healthcare to automotive – I combine requirements engineering, technical implementation, and governance understanding.

BioPharma & Process Science

Fermentation processes, upstream/downstream processes, LIMS integration

  • Requirements Engineering: stakeholder workshops with Process Science, QC, IT, and production
  • LIMS Consulting: LabWare LIMS v6/v7, custom frameworks, workflow design
  • System Integration: connection of analytical instruments, ERP integration, data flow design
  • GxP & CSV: validation-ready documentation, traceability, data integrity (ALCOA+)
  • Technology: C#/.NET, Oracle PL/SQL, REST APIs, OPC/UA

Many years of project experience in regulated BioPharma environments with a focus on laboratory automation and process digitalization.

Biotech & Laboratory Solutions

Synthesis of biopolymers, PCR diagnostics, LIMS development

  • LIMS Development: custom LIMS for peptide/DNA synthesis, workflow automation
  • PCR Test Kit Production: QA processes, IPC digitalization, shop floor integration
  • Requirements Engineering: user stories, use cases, interface specifications
  • System Design: data models, API design, integration patterns
  • Technology: C#/.NET Core, ASP.NET, SQL Server, Oracle, REST APIs

From requirements analysis and implementation to successful commissioning – one point of contact for all project phases.

Healthcare & Medical IT

Hospital information systems (HIS), third-party integrations

  • HIS Development: development work on hospital information systems
  • System Integration: PACS, medical devices, laboratory systems, HL7/FHIR
  • Requirements Engineering: stakeholder management (physicians, IT, administration, vendor)
  • Interface Design: REST APIs, message queues, data models
  • Compliance: medical device regulations, data protection (GDPR), documentation

Experience in the development and integration of complex healthcare IT solutions with high requirements for availability and data security.

Other Industries

Automotive, Legal Tech, Contract Management

Automotive:

  • GPS-based rail control solution
  • Real-time data processing, C#/.NET, Azure IoT Hub

Legal/Contract Management:

  • Development of a contract generator
  • Template engine, workflow automation, document management
  • Requirements engineering, user stories, system design

Cross-industry experience in the development of tailored software solutions.

Shop Floor Integration / Manufacturing Execution

Planning and commissioning of complex production lines – a cross-domain principle

Project Experience: PCR Test Kit Production
  • IPC Digitalization: in-process control for production & QA
  • Shop Floor Integration: connection of manufacturing equipment, packaging lines, quality inspection stations
  • OPC/UA Integration: standardized machine-to-machine communication
  • Data Acquisition: real-time data transmission, traceability, batch tracking
  • MES Functions: production scheduling, material flow, quality gates
Technical Implementation & Methodology
  • Requirements Engineering: workshops with production, QA, IT, and automation engineering
  • System Architecture: edge computing, message queuing, data aggregation
  • Technology Stack: C#/.NET, OPC/UA, Azure IoT Hub, SQL Server, REST APIs
  • Commissioning: FAT/SAT support, commissioning support, production ramp-up
  • GxP Compliance: CSV-compliant documentation, data integrity, audit trail

Cross-Domain Principle:

The concepts of shop floor integration – OPC/UA-based machine connectivity, real-time data acquisition, MES functionalities, and traceability – can be applied across industries: from BioPharma and Food & Beverage to automotive. My strength lies in recognizing these patterns, structuring requirements, and implementing them in a technically robust way – regardless of the production environment.

Project outcome: fully digitalized production line with end-to-end batch traceability, automated quality data acquisition, and GxP-compliant documentation – from concept to successful go-live.

Cross-Industry Core Competencies

Requirements Engineering
  • IREB/CPRE certified
  • Stakeholder workshops & management
  • Use cases, user stories, UML
  • Traceability & documentation
Software Development
  • C# / .NET Core / ASP.NET
  • REST API design & implementation
  • Oracle, SQL Server, Azure
  • System integration, OPC/UA
Regulated Environments
  • GxP & CSV (Computer System Validation)
  • Data Integrity (ALCOA+)
  • Validation-ready documentation
  • Audit-proof traceability

My added value: I combine requirements engineering, project management, and technical development in one person – from stakeholder workshops and concept design to productive implementation.