REMOTE Microbiologist-Sterilization

The Planet Group

Brooklyn Park Minnesota

United States

Scientific Research
(No Timezone Provided)

Top skills needed:

  • Practical experience applying the listed external standards, especially ISO 11135, ISO 11737, and AAMI ST72
  • Ability to work independently to meet milestones on a long term projects
  • Ability to effectively communicate progress and challenges to project team to ensure deadlines are met
  • Responsibilities may include the following and other duties may be assigned:

  • Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices
  • Complete studies needed to address compliance requirements for medical device microbial control and sterility
  • Create and/or update technical documentation, programs, and processes as needed to align with EU MDR and international regulation and standard guidance
  • Collaborate with internal and external crossfunctional teams to ensure successful implementation of program/process changes needed to meet regulations
  • Train and adhere to quality system procedures applicable to products in scope of responsibilities
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience (Medical Device and/or Microbiological Laboratory), or advanced degree with 0 years of experience.

    Preferred Qualifications:

  • Familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
  • Understanding of different types of sterilization methods (EtO, radiation, steam, etc.) including processes and equipment
  • Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO), ISO 11737 (Microbial Method, ISO 10993 (Biocompatibility), ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN).
  • Proven collaborator and team player.
  • Excellent organizational and judgment.
  • Ability to maintain and generate accurate records.
  • Strong written and verbal communication skills
  • REMOTE Microbiologist-Sterilization

    The Planet Group

    Brooklyn Park Minnesota

    United States

    Scientific Research

    (No Timezone Provided)

    Top skills needed:

  • Practical experience applying the listed external standards, especially ISO 11135, ISO 11737, and AAMI ST72
  • Ability to work independently to meet milestones on a long term projects
  • Ability to effectively communicate progress and challenges to project team to ensure deadlines are met
  • Responsibilities may include the following and other duties may be assigned:

  • Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices
  • Complete studies needed to address compliance requirements for medical device microbial control and sterility
  • Create and/or update technical documentation, programs, and processes as needed to align with EU MDR and international regulation and standard guidance
  • Collaborate with internal and external crossfunctional teams to ensure successful implementation of program/process changes needed to meet regulations
  • Train and adhere to quality system procedures applicable to products in scope of responsibilities
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience (Medical Device and/or Microbiological Laboratory), or advanced degree with 0 years of experience.

    Preferred Qualifications:

  • Familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
  • Understanding of different types of sterilization methods (EtO, radiation, steam, etc.) including processes and equipment
  • Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO), ISO 11737 (Microbial Method, ISO 10993 (Biocompatibility), ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN).
  • Proven collaborator and team player.
  • Excellent organizational and judgment.
  • Ability to maintain and generate accurate records.
  • Strong written and verbal communication skills