Freelancer with more than 10 years of experience in monitoring sterile medical devices based on ISO 11137-2 & -3
Expert in the analysis of microbiological organisms and method development for sterilization based on this analysis
One of the few experts with both extensive technical knowledge and practical knowledge of the complete sterilization validation process
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Diploma in Chemistry & Haematology
- Language Skills
- Dutch (native), German (business fluent), English (business fluent)
- Relevant Expertise
- Sterilization Validation, Gamma and EtO Sterilization, ISO 11137, FDA, E-beam, Cleanroom, Microbiological Monitoring, Bioburden, Bacteriostasis, Fungistasis, ISO 11737, Process Validation, Pharma, Biotech, MedTech
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Sterilization Consultant
Support for technical documentation for radiation sterilization
Quality Management
Product validation
Dose mapping
Biotechnological Company, Netherlands
Sterilization Consultant
Support for the technical documentation for gamma sterilization
Process Validation
Microbial Validation
Development and validation of methods
Maintaining process effectiveness
Biotechnological Company, Switzerland
Sterilization Consultant
Ongoing consultation in the areas of gamma and EtO Sterilization
Method validation
Dose mapping
Medical Device Company, USA
Sterilization Consultant
Creation of product families
Reduction of dose-mapping processing categories for production facilities in GB, Slovenia, and Dominican Republic
Pharmaceutical Company, Netherlands
Consultant Radiation Sterilization
Support in the microbiological validation using gamma radiation
Packaging Company, France
Consultant Audit - Sterilization
Consulting for radiation sterilization für FDA inspection (zero FG; F483)
Support with Validation processes
Routine bioburden testing
Bioburden Validation
Bacteriostasis testing