References
Notable Projects
A selection of relevant projects in Pharma and MedTech environments.(listed only where no NDA applies)
Cleanroom Construction, Modernization & Process Development
- Planning and execution of cleanroom renovation and modernization projects, including risk analyses, URS development, qualification planning, project coordination, and on-site construction supervision.
- Qualification of cleanrooms and associated equipment, including validation of related processes.
- Optimization of cleanroom processes, consumables, and cleaning concepts with structured change management.
- Deviation management and coordination with internal SMEs for cleanroom-related topics.
Training & Mentoring for Cleanroom Professionals
- Onboarding and training programs for cleanroom operators and technicians.
- Training and mentoring for cleanroom subject matter experts (SMEs).
- Technical support and expert guidance, including peer reviews.
- Harmonized implementation of cleanroom practices across multiple sites.
Implementation and Optimization of Environmental Monitoring in Vaccine Manufacturing
- Development and implementation of a risk-based cleanroom environmental monitoring system.
- Preparation of risk assessments and room documentation to define appropriate sampling locations.
- Support in the development of SOPs for environmental monitoring.
- Development, implementation, and validation of an Excel-based documentation system with audit trail, serving as an interim solution until LIMS implementation.
Qualification of Pharmaceutical Cleanrooms
- Participation in an expert team responsible for the qualification of a newly constructed industrial cleanroom for vaccine manufacturing (650 m²).
- Development and execution of risk assessments, qualification protocols, and environmental sampling plans.
Computer System Validation (CSV) for LIMS and Manufacturing Systems (Oncology)
- Development and execution of computer system validation (CSV) activities for the implementation of a new LIMS and manufacturing system across multiple pharmaceutical cleanroom sites.
- Implementation in accordance with GMP Annex 11 and GAMP 5 guidelines.
Implementation of Quality Management Systems for Pharmaceutical Cleanrooms
- Development and implementation of audit-ready quality management systems (QMS) in pharmacy and hospital cleanroom environments as a subcontractor for multiple TÜV SÜD clients.