Freelancer profile translated to English.
Back to original languageAbout Norbert
Interim Manager | Project Manager | Strategic Process & Risk Management Expert | HSE, Quality & Supplier Management | Life Sciences, Medical Technology, Automotive
About me: Experienced Interim/Project Manager with a focus on strategic management, end-to-end process optimization, risk management, and change. Leadership experience in R&D, software development (rail vehicles), medical technology, UV light, pharmaceuticals, and the chemical industry. Competent in construction site responsibility, HSE, supplier and budget management, as well as international transfers, design transfer, and life cycle management. Goal-oriented, solution-oriented, and resilient; strong in stakeholder communication, decision-making, and implementation of complex projects.
Areas of Expertise:
Interim Manager / Project Manager: Strategic processes, business strategy, risk management, quality & change management, supplier and budget management, production and complaint management
Leadership in R&D, Software (Rail Vehicles), Medical Technology, UV Light, Pharma, Chemistry
Project Management in Construction Site Responsibility & HSE; Logistics/Supply Chain (Automotive)
Management of PM activities in development, industrialization & international transfers; Design Transfer support; technical leadership; escalation of critical issues; project meetings; closing & handover processes
Finance: CAPEX/OPEX, SPE budget approvals, project documentation
Key Competencies (Skills):
Strategic Planning & Process Management
Risk Management & Compliance
Multidisciplinary, International Project Management
Quality Management & Continuous Improvement
Change Management & Stakeholder Management
HSE, Occupational Safety & Environmental Protection
Supplier & Procurement Management
Successful International Transfers/Industrialization
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
- ZUDUBIAI ConsultantOctober 2025 - Today (10 months)Frankfurt am Main, GermanyAn AI consultant analyzes business processes, identifies potential for AI application, selects suitable AI technologies, develops solution concepts, supports implementation, evaluates economic viability and risks, and assists with change management, data protection, and ethics.Technical Understanding: Analyze business processes, define goals, derive measurable KPIsAI Strategy & Architecture: Select suitable AI technologies, design solution architecture, create roadmapsModeling & Data Science: Data preparation, feature engineering, model training, validationTools & Platforms: Python/R, ML libraries (e.g., Scikit-Learn, TensorFlow, PyTorch), SQL, Cloud services (AWS/Azure/GCP), MLOps fundamentalsData Management & Governance: Data quality, data ethics, data protection (GDPR), security aspects, data lineageEconomic Viability & ROI: Cost-benefit analyses, business cases, budgeting, time-to-valueProject & Change Management: Stakeholder management, requirements engineering, agile methods, risk managementCommunication & Moderation: Clear communication of technical concepts, presentation & workshop skillsEthics & Compliance: Transparency, fairness, explainability, auditabilityImplementation & Integration: Interfaces, API design, system integration, testing & deploymentQuality & Governance: Quality management, monitoring, logging, performance optimizationIndustry Knowledge: Domain-specific processes (e.g., Fintech, Healthcare, Retail)
- Ramp Up Pilot Facility BionTechInterim Project ManagerJuly 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 GmbHInterim Program ManagerOctober 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
- QMBTÜV Nord2015Ausbildung als Qualitäts Beauftragter
- State-certified Mechanical Engineering TechnicianMax Eight Schule Kassel1987staatlich geprüfter Maschinenbautechniker für Maschinen und Anlagen