Norbert Helmke
Interim Project Manager Ramp Up Pilot Facility
Experience
KI Consultant
ZUDUBI
Key Deliverables
AI Strategy & Roadmap Documented AI vision, strategic objectives, prioritized use cases, and implementation roadmap.
Use Case Portfolio & Business Cases Identified AI use cases including value assessment, feasibility analysis, and ROI estimation.
Solution Concepts & Architectures High-level AI solution designs, tool selection recommendations, and integration concepts.
Process & Integration Documentation Documentation of AI-enabled processes and interfaces within the organization.
Governance & Guideline Documents AI governance frameworks, ethical guidelines, data protection and compliance concepts.
Pilot Projects & Proofs of Concept (PoCs) Design, coordination, and evaluation of AI pilots and PoCs.
Training Materials & Workshops User guides, training sessions, workshops, and onboarding materials for employees.
Implementation Support & Monitoring Support during rollout, KPI definition, success measurement, and continuous optimization.
Interim Project Manager Ramp Up Pilot Facility
BionTech
- 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 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
- Claim Management
Interim Program Manager
OPTIMA packaging group GmbH
- Scaling of milestones and recruitment of additional employees
- Setting up the production lines together with the production manager
- Project management for the construction of complex pharmaceutical filling and packaging systems for international customers
- Processing of machine projects holistically from order receipt to acceptance by the customer
- Technical and commercial clarification, creation of project plans and monitoring of relevant milestones
- Main contact for international customers and participation in customer meetings
- Responsibility for site-specific project planning and execution, coordination with line PM
- Coordination with Contract & Controlling for legal aspects in contract management
- Ensuring profitability and customer satisfaction through project controlling, evaluating costs, quality and deadlines
- Control and coordination of project-related deadline claims
- Planning and implementation of integrated lines at SHA and customer sites
- Single Point Of Contact on site
- Claim Management
- Execution of validation and verification measures, FAT and SAT at customer premises
Program Manager
Gerresheimer AG
- Leadership of global industrialization projects from incoming orders to project completion per SOP PM001
- Clarification of project contents and creation of project charter and deliverables list
- Management of qualification-validation strategies with customer and internal departments
- Creation of project structure plan and work package definitions
- Active leadership and coordination of project teams, conflict management
- Planning of project budget and invoicing deadlines (Cash Flow)
- Preparation and provision of reviews and regular project reporting on margin, milestones and risks
- Primary customer communication and stakeholder management
- Document filing and guarantee of GDP compliance
- Project controlling and monitoring of milestones, commercial goals and risk minimization
- Management and coordination of change management
- Claim Management
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (1 year), Information Technology (0.5 years), Professional Services (0.5 years), and Manufacturing (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Project Management (1 year), Quality Assurance (1 year), Business Intelligence (0.5 years), Information Technology (0.5 years), Strategy (0.5 years), and Production (0.5 years).
Summary
I am an experienced interim and project manager with broad expertise in strategic management processes, business strategy creation, process management, and change management. I specialize in quality management, budget control, vendor management, and stakeholder management in highly regulated sectors like pharmaceuticals, medical technology, and automotive. I have successfully led complex projects such as production and ramp-up processes, receivables management, GMP-compliant solutions, and launching corporate identities. I’m well-versed in project management tools (e.g. MS Project, Primavera) and SAP systems. I think logically, strategically, and with a strong customer focus, and I can manage multiple projects effectively at once.
Skills
Interim Manager
Project Manager
Change Management
Process Management
Quality Management
Supplier Management
Budget Management
Stakeholder Management
Gmp
Sap
Pharmaceuticals
Medical Technology
Automotive Industry
Business Strategy
Production
Operations
Receivables Management
R&d Team Leader
Project Management (Ms Project, Primavera)
Quality Management
Risk Management
Change Management
Process Management
Supply Management
Budget Management
Production Management
Complaint Management
Operations
Claim Management
Responsible, Highly Independent
Logical, Process-oriented, And Strategic Thinking And Acting
Customer-oriented And Able To Work Independently
Assertiveness And Strong Communication Skills
Good Understanding Of Mes And Lims
Team-oriented, Appropriate, And Goal-focused Work
Organization And Presentation Skills
Creativity And Design
Able To Manage Multiple Projects At The Same Time
Knowledge Of Core Business System (Sap)
Understanding Of Manufacturing Process Analytics
Good Functional And Technical Understanding Of Manufacturing Landscapes And Requirements
Ability To Work In A Regulated Environment With Knowledge Of Gxp Regulatory Documentation Framework
Ability To Drive The Completion Of Tasks Among Diverse Internal And External Stakeholders
Languages
Education
Technical Business Economist · Technical Business Economist
Technical College for Mechanical Engineering
Technical Engineer, with permission to instruct · Mechanical Engineering · Kassel, Germany
Certifications & licenses
Security Officer for Medical Devices
CATIA 5.0
TÜV Quality Representative (QMB) Part 2
TÜV Quality Representative (QMB) Part 1
Profile
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