Over Wolfgang
- AI adoption and implementation in regulated manufacturing
- EU AI Act classification and compliance for industrial/AI use cases
- GMP-grade AI architectures: RAG, agentic systems, and MCP integration
- Capex project management, technology transfer, and PMO build-up
- Operational readiness and validation (FAT/SAT, ENG/PPQ) in pharma and biotech
Duits
Tweetalig / moedertaal
Engels
Vloeiend
Werkervaring
- value companion s.r.o.Founding Partner & Head of Value SystemsCONSULTANCY & AUDITINGfebruari 2025 - Vandaag (1 jaar en 4 maanden)Prague, CzechiaAs Founding Partner and Head of Value Systems at value companion, I lead our consulting and delivery work around AI implementation for regulated industries — pharma, biotech, food & beverage, and industrial manufacturing.My role spans technical architecture, compliance strategy, and commercial development. On the technical side, I design AI-native systems built on the Model Context Protocol (MCP) — connecting AI agents to enterprise systems, documents, and data sources, with the governance that regulated environments require: audit trails, access control, data residency, and human-in-the-loop oversight. I work across the model-provider landscape (Anthropic Claude via AWS Bedrock EU, Mistral, OpenAI) with data sovereignty as a design principle.On the compliance side, I own EU AI Act self-assessment and classification, GDPR strategy, and the governance frameworks that make agentic AI defensible in a GMP-grade audit.On the commercial side, I drive go-to-market strategy, build our implementation-partner network with Lean and Six Sigma consultancies, and shape the multi-year roadmap together with my two co-founders.The throughline of my work: making AI implementation actually work in environments where generic AI tools fail compliance — where getting it wrong means a failed audit, not just a bad demo.
- SartoriusProject Manager — Product Lifecycle & Customer ProjectsPHARMACEUTISCHE INDUSTRIEmaart 2025 - november 2025 (8 maanden)Guxhagen, HE, GermanyLed strategic customer projects for a novel biotech system (ultrafiltration/diafiltration).Core responsibility was the successful transition of this product from thedevelopment phase into the established product portfolio. Led the cross-functionallifecycle team focused on continuous improvement and ongoing productdevelopment to sustain market success.
- Boehringer IngelheimSenior Project Manager / PMO DigitalizationPHARMACEUTISCHE INDUSTRIEjuli 2023 - juli 2024 (1 jaar)Ingelheim am Rhein, RP, GermanyGlobal digitalization and Industry 4.0 program for the vertical integration of production plants with central data acquisition and analytics. Standardized hybrid project management methods (waterfall and agile), implemented central PM tools with global rollout, and established data-driven transparency across all engineering projects. The experience with data-centric steering in a regulated pharma environment is the direct bridge to today's AI-driven analytics workflows.
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Opleidingen
- DIPLOM WIRTSCHAFTSINGENIEUR (FH)TFH2006DIPLOM WIRTSCHAFTSINGENIEUR (FH)
- AUSBILDUNG ZUM INDUSTRIEKAUFMANNWalter Bau AG/ Oberstufenzentrum Industrie und Datenverarbeitung2001AUSBILDUNG ZUM INDUSTRIEKAUFMANN
Diploma's
- PRINCE2 PractitionerPeopleCert
- Professional Scrum Master IScrum.org