Sterilization Specialist - Medical Devices
Michael Page
hace 7 días

Descripción de la vacante

The main responsibilities are to :

  • Participate in NPI projects defining the Customer requirements for these specialized areas.
  • Prepare the User Requirements Specifications for Sterilization, Microbiology, Cleanroom and Laboratory Testing.
  • Elaborate and execute Validation Protocols and Reports applicable for these areas (Sterilization Process Validations, Clean-
  • rooms Validations, Environmental Monitoring Systems Validation, Monitoring Equipment Validations, Water System Validation, Cleaning Validations, Analytical Methods Validations).

  • Update the Quality System Documentation and New Document Creation to be aligned to Customer and Regulation requirements for Sustaining.
  • Implement new Lab testing required.
  • Lead and follow up on Special Projects with Sterilization and Lab Services Suppliers.
  • Lead and participate in new projects preparation and presentation to the Management for Improvements and cost reduction.
  • Participate and support during third parties audits such as corporate ISO & FDA Audits.
  • Ensure GMP, ISO, QSR Regulations and Standards are followed.
  • Perfil del candidato

    Degree in Science with major in Biology or Chemistry. At least 5 years of experience in Sterilization Processes, Clean-room Monitoring / Standards and Laboratory Testings.

    Results driven, good interpersonal and organizational skills, proficient and ability to solve problems. Fluent English and availability to travel.

    Oferta de empleo

  • Benefits above law
  • Attractive compensation package
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