Visp, Valais, Switzerland
I am a dynamic, creative, innovative and logical thinker who enjoys problem solving. I am well-organised, goal oriented, and work well under pressure. I have authored technical reports as well as numerous equipment and software qualification documentation. I have also led root cause analysis sessions associated with complex process related GMP deviations. I am an ambitious and driven individual who is focused on continuous development to achieve my goal of becoming a process development and optimisation engineer. Please feel free to contact me through my email or using LinkedIn's messaging service.
- Performance Qualification (PQ) and Cycle Development (CD) of Autoclave loads and Steam In Place (SIP) vessel skids, within fill finish Grade C environment. - Operation of Lives thermal mapping software and creation of reports and documentation. - Troubleshooting process issues, authoring Deviations and implementing Corrective and Preventive Actions (CAPA). - Troubleshooting issues with validation equipment. - Design and implementation of Metrics for the optimisation of documentation and execution tasks using six sigma principles.
- Thermal mapping qualification and validation of bioreactors and addition vessels. - Organising and carrying out Process Qualification (PQ) and Cycle Development (CD) on steam in place (SIP) recipe level batches. - Using Delta V to run SIP cycles, record process data and troubleshoot issues. - Generation and execution of IOQ, PQ and RQ of lab equipment including incubators, fridges, freezers and temperature-controlled storage rooms. - Subsequent analysis of data and summary report generation. - Experience in carrying out Root cause analysis, deviations and CAPAs. - Generation, review, approval and execution of GMP and GEP documentation. - Knowledge of thermal mapping software including the use of Kaye Val probes and thermocouples with the TQsoft. - Creating a Software IOQ, SOP and URS for TQSoft.