The Microbiology Technician will work primarily with Philips Volcano products and processes that require sterilization and/or environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices. Is responsible of Controlled Environment Areas, routine environmental monitoring and prepare trending and reports. Compressed Dry Air sampling, product and bioburden analysis. Participate in sterilization process validations (ETO), prepare biological indicators tests for sterilization process, and execute support activities for the micro lab administration. Support and execute equipment and microbiological methods test methods validations. Perform endotoxin testing from final product and water samples
KNOWLEDGE AND EXPERIENCE DESIRABLE:
English knowledge written and spoken
Office knowledge (word, excel, powerpoint)
Desirable knowledge and understanding of GMPs, FDA regulations, Quality System Regulations (QSR), ISO 13485 requirements and Japan regulations.