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Norbert HelmkeNH

Norbert Helmke

Senior Projekt Manager Medizintechnik, Pharma

€900/day
Frankfurt am Main, DE
8-15 years

Average response time: 1 hour

About Norbert

Interim Manager | Projektmanager | Strategische Prozess- & Risikomanagement-Experte | HSE, Qualitäts- & Lieferantenmanagement | Life Sciences, Medizintechnik, Automotive

Über mich (About): Erfahrener Interim-/Projektmanager mit Fokus auf strategisches Management, End-to-End-Prozessoptimierung, Risikomanagement und Change. Führungserfahrung in R&D, Softwareentwicklung (Schienenfahrzeuge), Medizintechnik, UV-Licht, Pharma und chemischer Industrie. Kompetent in Baustellenverantwortung, HSE, Lieferanten- und Budgetmanagement sowie internationalen Transfers, Design Transfer und Life Cycle Management. Zielorientiert, lösungsorientiert und belastbar; stark in Stakeholder-Kommunikation, Entscheidungsfindung und Umsetzung komplexer Vorhaben.

Erfahrungsschwerpunkte:
Interim Manager / Projektmanager: Strategische Prozesse, Geschäftsstrategie, Risikomanagement, Qualitäts- & Change-Management, Lieferanten- und Budgetmanagement, Produktions- und Beschwerdemanagement
Führung in R&D, Software (Schienenfahrzeuge), Medizintechnik, UV-Licht, Pharma, Chemie
Projektmanagement in Baustellenverantwortung & HSE; Logistik/Supply Chain (Automotive)
Leitung von PM-Aktivitäten bei Entwicklung, Industrialisierung & internationalen Transfers; Design Transfer-Unterstützung; technische Führung; Eskalation wichtiger Fragen; Projektmeetings; Abschluss- & Übergabeprozesse
Finanzen: CAPEX/OPEX, SPE-Budgetgenehmigungen, Projektdokumentation

Schlüsselkompetenzen (Skills):
Strategische Planung & Prozessmanagement
Risikomanagement & Compliance
Multidisziplinäres, internationales Projektmanagement
Qualitätsmanagement & Continuous Improvement
Change Management & Stakeholder-Management
HSE, Arbeitssicherheit & Umweltschutz
Lieferanten- & Beschaffungsmanagement
Erfolgreiche internationale Transfers/Industrialisierung

Mit freundlichen Grüßen / Kind regards
Norbert Helmke
Internet:


  • French

    Basic

  • Spanish

    Basic

  • German

    Native or bilingual

  • English

    Conversational

Can work on-site
Frankfurt am Main (up to 50km), Bad Homburg vor der Höhe (up to km), Darmstadt (up to km), Wiesbaden (up to km), München (up to km), Berlin (up to 100km)

Experience

  • ZUDUBI
    KI Berater
    October 2025 - Today (10 months)
    Frankfurt am Main, Germany
    Ein KI-Berater analysiert Geschäftsprozesse, identifiziert Potenziale für KI-Einsatz, wählt passende KI-Technologien, entwickelt Lösungskonzepte, begleitet Implementierung, bewertet Wirtschaftlichkeit und Risiken, und unterstützt Change Management sowie Datenschutz/Ethik.

    Fachliches Verständnis: Geschäftsprozesse analysieren, Ziele definieren, messbare KPIs ableiten
    KI-Strategie & Architektur: passende KI-Technologien auswählen, Lösungsarchitektur entwerfen, Roadmaps erstellen
    Modellierung & Data Science: Datenaufbereitung, Feature Engineering, Modelltraining, Validierung
    Tools & Plattformen: Python/R, ML-Bibliotheken (z. B. Scikit-Learn, TensorFlow, PyTorch), SQL, Cloud-Dienste (AWS/Azure/GCP), MLOps-Grundlagen
    Datenmanagement & Governance: Datenqualität, Datenethik, Datenschutz (DSGVO), Sicherheitsaspekte, Data Lineage
    Wirtschaftlichkeit & ROI: Kosten-Nutzen-Analysen, Business Case, Budgetierung, Time-to-Value
    Projekt- & Change-Management: Stakeholder-Management, Requirements Engineering, Agile Methoden, Risikomanagement
    Kommunikation & Moderation: verständliche Vermittlung technischer Konzepte, Presentations- & Workshop-Fähigkeiten
    Ethik & Compliance: Transparenz, Fairness, Erklärbarkeit (Explainability), Auditierbarkeit
    Implementierung & Integration: Schnittstellen, API-Design, Systemintegration, Testing & Deployment
    Quality & Governance: Qualitätsmanagement, Monitoring, Logging, Performance optimieren
    Branchenwissen: domänenrelevante Prozesse (z. B. Fintech, Gesundheitswesen, Einzelhandel)


    Change Business Analysis Agile Methode
  • Ramp Up Pilot Facility BionTech
    Interim Projectmanager
    July 2024 - Today (2 years and 1 month)
    • Assumption of a wide range of tasks and responsibilities, in the commissioning of a pharmaceutical production plant, in the area of payment verification and document storage
    • Project management, control and follow-up of various issues in the areas of IT, SHE, technology, production, laboratory and supply chain
    • Preparation of project management documents and moderation of project meetings
    • Creation of documents from the areas of IT, SHE, technology, production, laboratory and supply chain that are necessary for the start of operations
    • Support and optimisation of administrative processes necessary for the start of operations
    • Reporting to the Site Leadership Team and relevant stakeholders
    • Assumption of a wide range of tasks and responsibilities, in the commissioning of a pharmaceutical production plant, in the area of payment verification and document storage
    • Project management, control and follow-up of various issues in the areas of IT, SHE, technology, production, laboratory and supply chain
    • Preparation of project management documents and facilitation of project meetings Creation of documents from the areas of IT, SHE, technology, production, laboratory and supply chain that are necessary for the start of operations
    • Support and optimization of administrative processes necessary for the start of operations Reporting to the Site Leadership Team and relevant stakeholders
  • OPTIMA packaging group GmbH
    Interim Program Manager
    October 2023 - February 2024 (4 months)
    • Project management for the construction of complex pharmaceutical filling and packaging systems for international customers, first point of contact and manage customer activities with the support of the specialist departments.
    • Processing of machine projects holistically from order receipt to acceptance by the customer. Central contact for all parties involved.
    • Technical and commercial clarification. Creation of project plans and monitoring of relevant milestones.
    • Main contact for international customers.
    • Participation in customer meetings. Plan and lead internal project team meetings with all participants.
    • Responsibility for site-specific project planning and execution, taking into account personnel and production capacities in coordination with the line PM.
    • Coordination with the project management Contract & Controlling to check the legal aspects in contract management and to prepare additional necessary offer supplements.
    • Ensuring profitability and customer satisfaction through project controlling, evaluating costs, quality and deadlines and reporting to the portfolio manager.
    • Control and coordinate project-related deadline claims and coordinate with the relevant interfaces.
    • The creation and monitoring of the specified schedule and, if necessary, the initiation of measures is the responsibility.
    • Responsible as an interface between the individual departments for monitoring the error analyses and their corrections.
    • The planning and implementation of integrated lines in SHA and at the customer's site.
    • Planning and implementation of contribution concepts.
    • Manage, plan and report the open points.
    • SPOC (Single Point Of Contact) on Site

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Education

  • QMB
    TÜV Nord
    2015
    Ausbildung als Qualitäts Beauftragter
  • staatl. geprüfter Maschinenbautechniker
    Max Eight Schule Kassel
    1987
    staatlich geprüfter Maschinenbautechniker für Maschinen und Anlagen

Skill set

Categories