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Microbiologist II

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Diasorin

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Location:
United States , Stillwater, Minnesota

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Category:
Research and Development

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Contract Type:
Employment contract

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Salary:

80000.00 - 100000.00 USD / Year
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Job Description:

Support the Operation teams as a subject matter expert, in performing troubleshooting and investigation into Bioburden and Environmental failures. Strong working knowledge of quality system regulations/requirements and ability to implement changes where necessary.

Job Responsibility:

  • Conduct routine analysis of products, stability samples, validation samples and Environmental samples through testing, data analysis/interpretation, method validation and continuous improvement projects
  • Develop, review and revise standard operating procedures
  • Train laboratory personnel on microbiological test methods
  • Initiate, investigate and execute NCRs, deviations, change plans and out-of-spec results as necessary
  • Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices
  • author and review technical or quality methods, procedures, protocols and reports in accordance with GDP
  • Monitor trending of Bioburden and Environmental test results
  • Investigate and facilitate the solving of equipment/facility environmental and bioburden problems
  • Perform vendor sourcing and selection of supplies
  • Present technical information in formal settings
  • Perform equipment qualifications as necessary
  • Generate ideas leading to new or improved products and internal processes and help to implement where necessary
  • Perform other special projects and duties at the discretion of immediate manager

Requirements:

  • BS/MS in Microbiology or a relevant field required
  • 5+ Years of experience working as a Microbiologist in Biotech, Pharmaceutical, Medical Device or cGMP regulated industry required
  • Experience with Bioburden/growth determination systems and aseptic methods
  • experience with gram negative and gram positive, anaerobic bacteria, environmental fungi identification and testing methodologies required
  • Strong knowledge of quality system regulations/requirements (FDA, EU, ISO, USP)
  • Excellent written and verbal communication skills, excellent documentation and organizational skills
  • Demonstrated critical thinking skills and attention to detail
  • Ability to take ownership of assigned tasks and responsibility for the results
  • Ability to perform multiple tasks
  • Ability to work in a team environment and interact with various departments
  • Ability to train others in the area functions needed for performance of job and review work for accuracy and alignment with procedures
  • Intermediate proficiency in MS Word, PowerPoint and Excel skills and statistical programs (i.e. Minitab), Google Suites
What we offer:
  • comprehensive plan of health benefits
  • retirement and financial wellbeing
  • time off programs
  • wellbeing support and perks
  • may be eligible to participate in an annual incentive program

Additional Information:

Job Posted:
February 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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