Philips Microbiology Coordinator in Alajuela, Costa Rica

The Microbiology Coordinator will work primarily with Volcano products and processes that require environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices. This position will provide cleanroom management expertise relative to the environmental control of clean rooms managed by Volcano, assuring they meet established applicable regulatory requirements. This position will establish and maintain processes, document validation protocols, investigate and drive appropriate corrective/preventive actions relative to non-conformance issues, on-going trending of environmental and sterilization data.

KNOWLEDGE AND EXPERIENCE:

  • Requires 2+ years experience in a microbiology function within the bio-medical, medical device, or pharmaceutical industry.

  • Knowledgeable in the following Microbiology tests: LAL, Bioburden, Biologic Indicator (BI), Water sampling, pH testing, Environmental Monitoring

  • Demonstrated experience, proficiency and strong technical expertise regarding microbial identification, sterility assurance, contamination control and clean room testing procedures, technique and methods.

  • Knowledgeable of FDA regulations, Quality System Regulations (QSR), ISO 13485, Good Laboratory Practices (GLP) and Japan regulations.

  • Knowledgeable of ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products Ethylene oxide — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical device and Part 2: Guidance on the application of ISO 11135-1

  • Knowledgeable of ISO 14644-1 through 14644-9: Clean rooms at http://en.wikipedia.org/wiki/Cleanrooms and associated controlled environments

The Microbiology Coordinator will work primarily with Volcano products and processes that require environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices. This position will provide cleanroom management expertise relative to the environmental control of clean rooms managed by Volcano, assuring they meet established applicable regulatory requirements. This position will establish and maintain processes, document validation protocols, investigate and drive appropriate corrective/preventive actions relative to non-conformance issues, on-going trending of environmental and sterilization data.

KNOWLEDGE AND EXPERIENCE:

  • Requires 2+ years experience in a microbiology function within the bio-medical, medical device, or pharmaceutical industry.

  • Knowledgeable in the following Microbiology tests: LAL, Bioburden, Biologic Indicator (BI), Water sampling, pH testing, Environmental Monitoring

  • Demonstrated experience, proficiency and strong technical expertise regarding microbial identification, sterility assurance, contamination control and clean room testing procedures, technique and methods.

  • Knowledgeable of FDA regulations, Quality System Regulations (QSR), ISO 13485, Good Laboratory Practices (GLP) and Japan regulations.

  • Knowledgeable of ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products Ethylene oxide — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical device and Part 2: Guidance on the application of ISO 11135-1

  • Knowledgeable of ISO 14644-1 through 14644-9: Clean rooms at http://en.wikipedia.org/wiki/Cleanrooms and associated controlled environments