Laboratory Microbiologist II

Boston ScientificSaint Paul, MN
274d$58,200 - $110,500

About The Position

The Laboratory Microbiologist II assists with the implementation of new test methods, equipment qualifications, and the development of non-routine testing protocols in the microbiology lab. He/she/they are responsible for the execution and support of various routine tests, such as: bacterial endotoxin, product bioburden, EO residual, microbial identifications, and other tests as assigned. He/she/they are responsible for lab-related support activities necessary for on-going maintenance of lab, including supply management, equipment maintenance, and data approvals.

Requirements

  • Bachelor's degree (Biology, Chemistry, or Microbiology are preferred)
  • 1+ years of related experience
  • Must be able to physically manipulate various medical devices and products in a controlled and aseptic manner which may require standing for extended periods of time

Nice To Haves

  • Experience working in microbiology and/or regulated laboratories
  • Previous experience with any of the following test methods: Bacterial Endotoxin testing, Product Bioburden testing, Reusable Device Reprocessing Validations, Gas Chromatography / EO Residual

Responsibilities

  • Lead Bioburden test method(s): Perform testing, data analysis, and reporting activities for routine Bioburden, Heat Shock (spore), and Water Microbial methods, Adverse Substance Screening.
  • Investigate unexpected test results and method execution challenges.
  • Develop solutions to solve specific issues. Drive the implementation of general process changes to support continuous improvement culture.
  • Collaboration with device design matter experts to develop sample specific Inoculation Recovery studies and author subsequent device extraction protocols.
  • Support Reusable Medical Device Reprocessing Validations: Participate in the execution of manual and automated cleaning validations protocols and creating standard curves for different analytes using a spectrophotometer.
  • Performance of product disinfection validations and maintaining appropriate microorganism culture collections.
  • Execute sterilization validations using biological indicator spore strips.
  • Conduct general laboratory support functions such as reviewing inventory, ordering, and receiving supplies; support of continuous laboratory cleanliness; collecting, washing, and storing glassware.
  • Perform a variety of technical support functions such as performing basic equipment preventive maintenance; preparing routine solutions and reagents; and assisting in general equipment/process troubleshooting activities.
  • Perform technical and record keeping duties in conformance with company and regulatory standards to meet quality and accuracy requirements. Proficiency in technical writing is a must.
  • Participate in lab continuous improvement activities to drive lean culture and improve the overall quality function of the lab.
  • Assist in investigations related to testing, which may include ownership of NCEPs and CAPAs.
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