Daniel

Daniel combines validation-oriented pharma IT, project leadership, data-driven delivery, and pragmatic AI implementation.

Daniel is a computer scientist with long-standing experience across regulated pharma environments, banking, risk management, and energy trading. His work consistently sits at the intersection of business process understanding, technical implementation, and delivery ownership. That combination makes him particularly effective in projects where requirements are complex, systems are interconnected, and documentation quality matters.

He works comfortably across strategy, analysis, implementation, and rollout. Depending on the situation, that can mean shaping governance models, leading validation activities, structuring a migration, building Python-based automation, designing system interfaces, or turning AI ideas into usable internal tools.

Focus Areas

  • Computer System Validation (CSV) and GAMP5-oriented delivery
  • Artificial intelligence, RAG, and automation workflows
  • Business analysis and systems analysis
  • Project and stakeholder management
  • Process design and governance
  • Python-based implementation and technical prototyping

Working Style

Daniel tends to be most valuable where organizations need both structure and progress. He helps teams translate between business, quality, and IT, keeps workstreams aligned, and stays close enough to implementation to make sure concepts hold up in practice. His approach is pragmatic rather than theatrical: clear scope, understandable documentation, realistic rollout paths, and solutions that can actually be operated afterwards.

Project Experience

Historian System Validation for Multiple Sites

Led and supported CSV work for historian-system validation across different customer and site contexts. The work covered the full GAMP5 lifecycle, including validation planning, user requirements, risk assessment, functional and design specifications, IQ/OQ/PQ, traceability, and final reporting.

Accounty Open-Source Accounting Agent

Created the open-source project Accounty, a local-first accounting assistant with a web UI. The solution reads invoices, prepares SEPA payments via FinTS/HBCI, archives documents into Paperless-ngx, and keeps sensitive data in the user’s own environment. The project combines AI-assisted workflows with practical accounting operations instead of treating AI as a disconnected demo.

AI-Supported Generation of Validation Documentation

Designed and built an end-to-end documentation pipeline for Lua-based CSV validation scripts. The solution analyzed existing scripts and dependencies, generated technical descriptions and UML diagrams with ChatGPT, and exported the results into a branded Word-based documentation flow. This significantly reduced manual effort while improving consistency and updateability.

Custom RAG Solution for SOP Discovery

Designed and delivered an internal SOP question-answering assistant based on LangChain, ChatGPT, FAISS, and SQL-backed sources. The work included requirements engineering, architecture design, implementation, and deployment. The result was a much more usable way for teams to locate relevant procedures quickly and with better traceability.

PDF-to-Platform Migration with OCR and Automation

Built an automation flow to migrate handwritten PDF-based requests into a new online platform. The solution combined OCR and LLM-based extraction, data normalization, staging in SQLite, and Selenium-based upload automation. The overall flow reduced manual entry effort and made legacy form migration more scalable and controlled.

Process Automation with RPA Platforms

Evaluated operational processes for automation potential, defined target automations, implemented selected solutions with RPA tooling, and supported rollout. The work focused on making process improvements concrete and operable rather than stopping at conceptual automation ideas.

Data Harmonization and Dashboarding

Integrated and transformed data from multiple sources, including CRM, database, and analytics files, into Qlik Sense. Built dashboards and stories to improve transparency, reporting quality, and shared understanding across stakeholders.

Governance Application Retirement and Archiving

Supported the retirement of a governance-related application and the secure handling of its data and archive requirements. The work combined analysis, structured transition planning, and attention to validated-state expectations.

AI-Supported Migration of Legacy Governance Data

Created a concept and implementation path to extract data from different source applications, transform it with Python and AI support, and upload it into a new governance platform. This work linked technical migration tasks with process understanding and documentation needs.

Governance and Digital Solutions for Patient Support Processes

Contributed to governance processes for patient support initiatives in a global and regulated setup. This included shaping process structures, supporting approvals and maintenance workflows, and aligning digital tooling with business and compliance expectations.

Validation Management for Regulated Salesforce Environments

Served as validation manager for multiple Salesforce instances in a GxP-relevant environment. The work included documentation according to GAMP5, close collaboration with global teams, and sustained attention to audit and inspection readiness.

Audit Coordination and CAPA Follow-Up

Coordinated CSV audit preparation and execution, joined audit interviews, supported audit reporting, and drove CAPA follow-up activities. In parallel, worked on process consulting initiatives to redesign study-related local processes through workshops, SOP integration, and structured documentation.

Python Workshops and Technical Enablement

Designed and delivered Python workshops for beginner and advanced audiences. The workshop series covered practical programming foundations as well as more advanced topics, including an introduction to artificial intelligence with TensorFlow.

Risk-Based Approach in Salesforce

Analyzed an existing risk-based process model and integrated it into a Salesforce-based environment. The work combined business analysis, solution design, system maintenance, and support for the surrounding governance process.

Reference Data System Definition for Financial Regulation

Defined reference-data requirements against regulatory expectations and business processes in a capital-markets context. The assignment included process management, requirements engineering, solution design, and support for junior consultants.

Risk Capital Reporting Enhancement

Worked on the enhancement of local risk capital reporting in a highly structured financial environment. Responsibilities included target operating model definition, business and data process analysis, tool selection, workshops, sub-project management, and stakeholder alignment.

Data Quality Integration for Risk Metrics

Reviewed an existing key-risk-metric production process and aligned the associated data-quality approach with broader regulatory expectations. The work focused on strengthening process quality and control logic in a demanding governance environment.

Prototype for Risk-Adjusted Audit Planning

Supported the creation of a prototype for risk-adjusted audit planning. The emphasis was on analytical structuring and turning conceptual audit-planning ideas into a more concrete and testable solution.

Desk-Based Audit Approach Advisory

Supported the design of a desk-based audit approach, including work on hypothesis-based testing and the structuring of the supporting method.

Interfaces for Trading Confirmation Platforms

Worked on the integration and extension of interfaces to external trading-confirmation platforms in an energy-trading landscape. The role combined requirements analysis, process and systems analysis, coordination of offshore teams, test management, and delivery management.

Interface for Regulatory Reporting

Supported the design and delivery of an interface into a regulatory-reporting environment. The project again drew on detailed systems analysis, coordination across teams, testing, and dependable delivery.

Change Management on a Trading Floor

Managed small-scale but business-critical changes in an energy-trading environment. The work covered requirements analysis, cost estimation, planning, stakeholder communication, workshops, architecture analysis, test design, QA support, regression-test improvement, automated testing, and user enablement.

FX Hedging System Extension

Analyzed and documented the system landscape around FX hedging and contributed to application development, testing, and delivery in a trading context.

Code Quality and Standard Framework Improvement

Analyzed existing development frameworks and processes, developed a revised framework, and supported rollout of improved standards and ways of working.

3D Simulation Development

Built a 3D simulation for a positive-displacement machine in an engineering environment and developed related calculation metrics. This early work established a strong technical base in software development and analytical problem solving.