Norbert Helmke
Interim Project Manager Ramp Up Pilot Facility
Experience
Jul 2024 - Sep 2024
3 monthsInterim Projectmanager 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 facilitation of project meetings.
- Creation of necessary documents for start of operations from the areas of IT, SHE, technology, production, laboratory, and supply chain.
- Support and optimization of administrative processes required for the start of operations.
- Reporting to the Site Leadership Team and relevant stakeholders.
- Assumption of responsibilities in payment verification and document storage.
- Claim Management.
Oct 2023 - Feb 2024
5 monthsInterim Program Manager
Optima Packaging Group GmbH
- Project management for construction of complex pharmaceutical filling and packaging systems for international customers.
- Central contact for all involved parties from order receipt to customer acceptance.
- Technical and commercial clarification, creation of project plans, and monitoring of milestones.
- Responsibility for project planning and execution considering personnel and production capacities.
- Coordination with Contract & Controlling for legal aspects and additional offer supplements.
- Ensuring profitability and customer satisfaction through project controlling and reporting to the portfolio manager.
- Coordination of project-related deadline claims and error analyses correction.
- Implementation of integrated lines in SHA and at customer sites.
- Planning and reporting on open issues.
- Single Point of Contact (SPOC) on-site.
- Claim Management.
Mar 2023 - Sep 2023
7 monthsWackersdorf, Germany
Program Manager
Gerresheimer AG
- Leadership of projects and programs (e.g., global industrialization projects with investment positions).
- 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 definition of work packages.
- Active leadership, coordination of project teams, and conflict management.
- Planning project budget, milestones, and invoicing (Cash Flow).
- Customer communication and management.
- Regular preparation of project reportings on project margin, risks, and deliverables status according to GX GMS handbook.
- Document filing ensuring GDP compliance.
- Project monitoring and controlling.
- Management and coordination of change management.
- Claim Management.
Jul 2022 - Dec 2022
6 monthsIlmenau, Germany
Technical Project Manager
Avatera Medical
- Management of interdisciplinary project teams ensuring timely project planning and documentation.
- Regular project meetings and setting/monitoring milestones.
- Reporting and communication with customers. Participation in customer visits and support on-site.
- Project planning, scheduling, and controlling including cost/resource planning.
- Requirements management and ensuring product/process quality of international suppliers.
- Qualification of new suppliers and audits execution.
- Coordination with suppliers regarding sampling contents, process development, and qualification/validation.
- Supplier monitoring and evaluation.
- Incident Management and Claim Management.
Feb 2022 - Jun 2022
5 monthsSchorndorf, Germany
Technical Project Manager
Catalent
- Interface role between research, production, QA, QC, and logistics.
- Responsible for coordination from planning to market launch.
- Management of operations project team including budget, supply chain, and production targets.
- Development projects implementation coordinating with customers.
- Recipe preparation for customer drug form, scaling commercial production.
- Transfer projects and supplier monitoring/evaluation.
- Ensuring product quality of international suppliers.
- CAPEX projects up to €180 million.
- Incident Management and Claim Management.
May 2021 - Jan 2022
9 monthsMannheim, Germany
Program Manager / Senior Project Manager Operations
Roche Diagnostics
- Coordination of all functions: external partners, purchasing, production, logistics.
- Responsibility for planning to market launch within Global Operations.
- Technical leadership of project team ensuring cost, result, time, and quality targets.
- GMP conformity and compliance.
- CAPEX projects up to €250 million.
- Budget responsibilities for production, resources, and quality.
- Claim Management.
Oct 2020 - Apr 2021
7 monthsProgram Manager / Senior Project Manager
IDT Biologika
- Management and coordination of interdisciplinary project teams.
- Timely and cost-effective implementation of milestones for a major project.
- CAPEX projects up to €220 million.
- Cost control and accounting execution contents verification.
- Optimization/standardization process development.
- Claim Management.
Aug 2020 - Oct 2020
3 monthsProgram Manager / Senior Project Manager
Haselmeier
- Coordination between customer (USA), external development partner (USA), and project team in Germany.
- Supervision of sub-projects (assembly line setup, pharmaceutical production).
- Evaluation of injection molding production.
- Reporting to responsible department heads and documentation of progress/status.
- Planning and management of medical devices/connectivity projects.
- Ensuring project administration/documentation compliance.
- Interface illustration between development department and customer.
- Claim Management.
May 2020 - Jul 2020
3 monthsSenior Development Project Manager
Balda Medical GmbH & Co.KG
- Management of product developments for parenteral drug administration.
- Development of plastic components/systems for medical applications including CAD design.
- Coordination of tools for plastic parts creation, packaging, and labels.
- Proactive collaboration on documents for IQ, OQ, PQ.
- CAPEX projects up to €100,000.
- Claim Management.
Jul 2019 - May 2020
11 monthsFrankfurt am Main, Germany
Senior Technology Project Manager
Sanofi
- Project management during development, industrialization, and transfers.
- Design transfer support and technical leadership.
- Regular project meetings coordination within development.
- Financial tracking including CAPEX and OPEX.
- Establish and maintain project documentation.
- Compliance with regulatory requirements ensuring inspection readiness.
- CAPEX projects up to €120 million.
- Incident Management and Claim Management.
Summary
Team leader R & D
Project manager software development rail vehicles
Project manager Pharma
Project manager Medical device
Project manager technical Medical device
Project manager ultraviolet light
Project manager (construction site responsibility) and HSE for chemical industry
Project manager logistics, production, supply chain automotive supplier industry
Project manager introduction of new corporate identity of automotive industry
Interim manager Managing Director
Project management (MS Project, Primavera)
Quality management
Risk management
Change management
Process management
Supply management
Budget management
Production management
Complaint management
Operation claim management
Responsible, high degree of independence
Logical, process-oriented and strategic thinking and acting
Customer-oriented and independent working
Assertiveness and strong communication skills
Good understanding in MES and LIMS
Team oriented, appropriate and targeted work
Organization and presentation skills
Creativity and design
Able to manage several projects at the same time
Knowledge in core business system (SAP)
Manufacturing process analytics understanding
Good understanding (functional and technical knowledge) of manufacturing landscape and requirements
Ability to work in a regulated environment with a GxP regulation documents framework knowledge
Ability to drive the completion of activities among diverse internal & external stakeholders
Languages
German
NativeEnglish
AdvancedSpanish
ElementaryFrench
ElementaryItalian
Elementary Education
Oct 1985 - Jun 1987
Technical College for Mechanical Engineering Kassel
Technical Engineer with permission to instruct · Mechanical Engineering · Kassel, Germany
Certifications & licenses
GAMP
SOPs
CE
DIN ISO 13485:2016
ISO 10993 "Biological evaluation of medical devices"
ISO 13485:2016
IVD-guideline 98/79/EC
MDD 93/42/EEC
Six Sigma
21 CFR 820.100 "Corrective and preventive action"
Qualitätsbeauftragter TÜV (QMB) Part 2
TÜV
Qualitätsbeauftragter TÜV (QMB) Part 1
TÜV
510K
ISO 10007
ISO 10993 "Biological evaluation of medical devices"
ISO 13485
ISO 14971
GMP
DIN EN 60601
ISO 13485
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