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Microbiologist

Req ID: J2319651

  • Ubicación
    Le Locle, Neuchâtel, Switzerland
  • Categoría Investigacion & Desarrollo
  • Publicado jueves, 2 de junio de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

MAIN TASKS:

  • Establish and maintain procedures, tools and methodologies to cover the Jabil contamination control program (clean room monitoring, product monitoring, water monitoring, compressed air monitoring)
  • Conduct radiation sterilization validations according to ISO 11137, and establish/maintain the bioburden and dose audit programs
  • Maintain knowledge of FDA & ISO Environmental Monitoring and Product Cleanliness guidelines, as applicable
  • Conduct technical assessments and support audits as Subject Matter Expert for contract laboratories and critical suppliers
  • Conduct risk assessments from a contamination control perspective
  • Provide guidance and training to personnel to ensure contamination control program requirements and good manufacturing/good documentation practices are met
  • Work with the management to establish plant specific environmental monitoring requirements
  • Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy, for obtaining clean and safe products
  • Provide input on design of systems to generate processed water
  • Support validation of processed Water, controlled environment and finishing/cleaning processes
  • Evaluate changes in the manufacturing processes (i.e internal process changes, external process changes, product transfers, etc.)
  • Perform compliance tasks (CAPA, Nonconformances, Audit Observations) and support internal and external audits (Tüv, FDA, CFDA, etc.)
  • Support projects accross-sites (travel up to 30% to other production sites)

JOB REQUIREMENTS:

  • Bachelor or Master degree in Microbiology/Biology
  • At least 2 year's work experience in the medical device and/or pharmaceutical industry is a must
  • Experience with sterilization of medical devices is an advantage
  • Knowledge in Good Manufacturing Processes
  • Knowledge in regulations and industry guidelines applicable to cleanrooms (i.e. ISO/EN/AAMI standards) is preferred
  • This position requires the ability to interact with managers as well as manufacturing personnel
  • This position involves work in cross-functional groups, in an environment that embraces teamwork
  • This international company offers employees an environment that encourages talent development
  • Business fluency in French and English required, German would be an advantage
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