SME & Project Manager

With over 25 years of experience, he excels in procurement, qualification, validation, and implementation of laser welding systems, adhering to ISO 13485 and GMP standards

Proven expertise in technical project management for complex manufacturing projects, including time, cost and resource planning and stakeholder coordination at management level

Responsible for planning, tendering and procurement of production equipment with individual and total volumes up to 50 million euros

Possesses excellent knowledge in GMP-compliant documentation from URS, FS, DS to IQ/OQ/PQ and SOPs, and regularly participates in audit preparations

Technical leadership (SME) and project responsibility for the validation of manufacturing processes according to regulatory requirements (including IQ/OQ/PQ)

Member of the internal audit team with active participation in FDA audits and audits by notified bodies

Design and implementation of a company-wide CSV strategy to ensure regulatory compliance

Planning and introduction of new production lines and manufacturing processes, including qualification and training of personnel

Creation and implementation of key SOPs to standardize processes in a GMP-regulated environment

Conducting supplier and manufacturer audits to verify quality and compliance standards along the supply chain

Specialized audits for data integrity for manufacturing systems and electronic QM systems (eQMS)

Internal audit team (FDA audit & notified body)

Implementation of e-QM systems, QM systems, and CSV strategies

Introduction of new production lines and processes

Business continuity planning

Deployment and procurement of laser welding systems for ECMO products

Procurement of laser welding systems including specification creation and supplier selection

Responsible for conducting FAT/SAT and their complete documentation

Technical project management across all phases of system integration

Creation of technical documentation for qualification and validation (URS, FS, DS, IQ, OQ, PQ)

Ensuring domentation according to FDA/GMP guidelines

Coordination of risk analyses (FMEA, HAZOP) and their documentation

Communication with notified bodies for submission of project-critical documents

Implementation of worldwide DAQ systems in OT for multinational pharmaceutical manufacturers

Introduction of e-QMS, QM systems, and CSV strategies

Introduction of new production lines and processes

Project management for the integration of laser welding systems into existing production lines

Comparison of offers and procurement of technical equipment

Independent procurement of laser welding systems based on technical and regulatory requirements

Conducting and documenting FAT/SAT in close coordination with suppliers

Interface management between engineering, purchasing, production, and QA

Creation of technical documentation according to GAMP 5 and Annex 15

Support in the creation of SOPs and maintenance plans for new systems

Regular reporting to management and stakeholders

Validation of ERB systems

Introduction of e-QM and QM systems as well as CSV strategies

GMP cleaning consulting and training for medical device manufacturers

Introduction of new production lines

Implementation of laser welding technology in series production of medical products

Responsible for specification, tendering, and procurement of laser welding systems

Coordination of FAT/SAT and creation of all validation documents

Responsibility for project schedules, resource, and cost control

Preparation of technical specifications and functional specifications

Documentation of changes within the framework of design change processes

Creation and maintenance of qualification documents for authority audits

Environmental monitoring and consulting for SMEs

Conducting the entire procurement process for laser welding systems (including URS and offer evaluation)

Planning and coordination of FAT/SAT in an international environment

Introduction of QM and CSV systems

GMP cleaning consulting, R&D consulting for test equipment

Design transfer of new medical products

Responsibility for selection and procurement of laser welding systems

Coordination of FAT/SAT activities with international suppliers

Project management over the entire system lifecycle (from URS to SOP)

Creation and maintenance of technical documents for regulatory submissions

Quality documentation for system acceptance according to ISO 13485

Development of change control documentation for the introduction of new technologies

Introduction of QM, CAPA, complaint, and change management systems

GMP cleaning consulting, R&D consulting for test equipment

Training in the design process, packaging, and sterilization

New manufacturing processes

Integration of laser welding systems to optimize sterile packaging

Planning, execution, and documentation of FAT/SAT tests

Writing validation reports and risk analyses (e.g., RPA, PFMEA)

Preparation and maintenance of technical device files (DHF, DMR, DHR)

Creation of test instructions and production documentation according to GMP