Clean Room Specialist
Schott
- Lukácsháza, Vas
- Állandó
- Teljes munkaidő
- Implementation and provision of monitoring activities for clean rooms, technological media and products in accordance with the provisions of relevant guidelines
- Provision of basic data for environmental monitoring reports
- Participation in the monitoring and processing of deviations occurring in the scope of responsibility (initiation of CAPA for OOS & deviations in clean/ controlled areas), as well as in supporting CAPA measures and investigations in cooperation with other departments
- Participation or lead investigations for OOS and deviations
- Order nutrient media
- Hygiene concept: participation in monitoring of the implementation of the hygiene concept at the site
- Organization: general laboratory organization and administration (e.g. inventory management, orders, ensuring the calibration status of the devices used)
- Management the pest control process, keeping contact with external company, review external reports and initiates CAPAs as per the internal process/ limits
- Responsible for the light intensity measurements, planning of external measures, address local actions if needed
- Participation in the qualification and validation processes of the infrastucture (clean room, controlled area, WFI, compressed air), responsible for the control and compliance with the required standards
- Participation in the validation of microbiological process and test methods, preparation of reports
- Preparation/ support of URS of clean/ controlled rooms
- Participation in the implementation/ establishment and maintenance of the hygiene concept, its monitoring, dress code and clothing requirements and implementation of clean room check
- Initial GMP training for new employees (if necessary)
- Support assessments, projects and developments with knowledge/ experience of GMP
- Follow GMP and GDP rules and make others keep the rules; support the employees with training and technical instructions in consultation with their supervisors
- Support of process and product development through preparing risk analyzes related to bioburden, endotoxins and particle measurements, as weel as during sterilization processes and procedures
- BSc in natural science, microbiology, chemistry or biology
- Min. 2 years of experience in microbiological laboratory and clean room environment
- Experience in environmental monitoring
- Experience in bioburden test
- Knowledge of ISO 15378/ ISO 13485 / ISO 14644 standard, GMP
- Good command of English
- Problem solving skills (OOS & deviation management)