Clean Room Specialist

Job description

Environmental Monitoring:

• Administrating and maintaining Production IT systems according the central IT methods.
• Implementation and provision of monitoring activities for clean rooms, technological media and products in accordance with the provisions of the relevant guidelines (if necessary).
• 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 (if necessary).
• 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 the contact with external company, review external reports and initiates CAPAs as per the internal process / limits
• Responsible for the Light intensity measurements, planing of external measures, address local actions if needed.

Clean & Controlled room qualification:

• Participation in the qualification and validation processes of the infrastructure (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

GMP: concept and training:

• 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 to the rules. Support the employees with training and technical instruction in consultation with their supervisor.

Projects & developments:

• Support of process and product development through preparing risk analyzes related to bioburden, endotoxins and particle measurement, as well as during sterilization processes and procedures.

Required education and experience

• BSc in natural science, microbiology, chemistry or biology
• At least 2 years of experience in microbiological laboratory and in clean room environment
• Experience in environmental monitoring
• Experience in bioburden test
• Knowledge of ISO 15378 / ISO 13485 and ISO 14644 standard, GMP
• Good command of English
• Problem solving skills (OOS & deviation management)

Location        

• Vas county