Industries & Project Experience
From BioPharma to healthcare and automotive – I combine requirements engineering, technical implementation, and governance awareness.
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: integration 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
Several 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 through implementation to successful go-live – 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, vendors)
- 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 custom software solutions.
Shop Floor Integration / Manufacturing Execution
Design and commissioning of complex production lines – a cross-domain principle
Project Experience: PCR Test Kit Production
- IPC Digitalization: in-process control for production and QA
- Shop Floor Integration: integration of production equipment, packaging lines, and quality inspection stations
- OPC/UA Integration: standardized machine-to-machine communication
- Data Capture: real-time data transfer, 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 integration, real-time data capture, MES functionalities, and traceability – can be applied across industries: from BioPharma to 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 capture, 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-ready traceability
My added value: I combine requirements engineering, project management, and technical development in one person – from stakeholder workshops and concept work to productive implementation.