Team
Nils Arne Jonescheit
Approachable, hands-on consultant helping life-science manufacturers replace paper processes with lean, validated digital workflows. I focus on what works on the shop floor: standardizing core processes, integrating systems (MES, LIMS, equipment), and making data reliably available for compliance and continuous improvement. My style is straightforward, pragmatic, and anchored in Hanseatic integrity.
Key Experiences
- Assessment of production and quality processes; definition of target process models and digital user journeys
- Lean MES rollouts with phased value delivery and practical adoption plans
- Integration of validation from the start (risk-based CSV, traceability, test strategy)
- Shop-floor enablement through training, SOP/WI updates, and continuous support
- Process optimization and standardization across production and quality environments
- Digitalization of documentation and approvals (deviations, CAPA, logbooks, forms)
- Standardized templates for rapid roll-out across sites
- Validation packages for regulated use (requirements, UAT, release documentation)
- Connecting systems such as MES, LIMS, equipment, and ERP for a single flow of trusted data
- API/interface orchestration with focus on data integrity (ALCOA+)
- Visibility, analytics readiness, and standardized data for CI/lean initiatives
- Preparation of sites and systems for regulatory inspections and audits
- Development of digital-lean starter packages to establish compliant, efficient documentation practices
- Interim support in CSV, QA, and project management roles to accelerate delivery and remediation
- Sustainable reduction of compliance burden through harmonized, validated processes
- Validation packages for regulated digital systems (requirements, UAT, release documentation)
Technologies & Knowledge
Domains
- GxP/GMP, Data integrity (ALCOA+)
- MES, LIMS
- eBR, shop-floor & quality workflows
- Digital lean / continuous improvement
Platforms & Patterns
- Low-code application and workflow engines (Tulip, MasterControl MX)
- PAS-X (V2.x-3.x) / SAP ECC
- System integration via APIs/REST, message queues; equipment connectivity (e.g., OPC UA where applicable)
Methods
- Process analysis & value stream mapping
- Standardization & template design
- Change enablement, training, and shop-floor coaching
Ready to bring your digital vision to life?
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