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Team

David Kühl

MES consultant with deep expertise in Körber PAS-X, focused on translating manufacturing processes into compliant, efficient electronic workflows. I design and optimize MBR solutions for pharma and biotech, support validation and go-lives, and ensure systems integrate smoothly into regulated production environments. My approach is structured, technically grounded, and committed to delivering practical digital solutions that work.

 

David Kühl

Key Experiences


  • Design, configuration, and enhancement of PAS-X MES solutions across greenfield and brownfield projects
  • Development of electronic Master Batch Records (eMBR/MBR) tailored to manufacturing workflows
  • Translation of paper-based processes into robust, GMP-compliant digital execution
  • Support for integration with ERP, LIMS, and level 2 systems
  • Onsite and remote go-live/hypercare support for deployments and validation batches
  • Support of computerized system validation (CSV/CSA) activities including risk assessments
  • Development and review of validation documentation aligned with GAMP standards
  • Execution of FAT/SAT testing and documentation for regulated systems
  • Management of change controls (TrackWise) and test case reviews (HP ALM)
  • Development of standardized CSV frameworks, templates, SOPs, and GxP training
  • Management of PAS-X Content Package lifecycle for enhanced labels and reports
  • Implementation and maintenance of standardized content across production sites
  • System configuration aligned with data integrity (ALCOA+) and regulatory requirements
  • Guidance through ERP selection processes for pharmaceutical clients
  • Technical advisory on MES strategy, system architecture, and integration concepts
  • Support for clients in scoping and structuring digital transformation roadmaps

 Technologies & Knowledge 

Domains

  • PAS-X MES (V2.x–V3.x)
  • GMP/GxP compliance, GAMP standards
  • Electronic Master Batch Records (eMBR)
  • Process validation & data integrity

Platforms & Tools

  • Körber PAS-X
  • TrackWise, HP ALM
  • SAP ECC integration
  • Veeva QualityDocs

Methods

  • MBR design & workflow modeling
  • Risk-based validation (CSV/CSA)
  • FAT/SAT execution
  • Change management & training delivery


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