Senior Microbiologist

Overview

Element has an opportunity for a Senior Microbiologist to join our Eagan, MN laboratory, which specializes in microbiological testing and analytical support for antimicrobial, pharmaceutical, medical device, and related regulated manufacturing and consumer product industries. The senior microbiologist performs and evaluates both custom and standardized testing that supports client needs; generates data while maintaining a high level of scientific integrity; assists in the review of test results, raw data, and Certificates of Analysis;

designs and executes research and development (R&D) projects when implementing new methods or adapting current methods; maintains awareness of advances and changes in the test methodology; effectively communicates with management and others in the company to share information, offer ideas, and think creatively to effectively solve client testing problems to support registrations of new and novel antimicrobial products. In this role, you may also perform sterility and bioburden testing, environmental monitoring, and method qualifications.

This position plays a key role in executing testing within a cGLP and ISO 17025 environment, maintaining data integrity, and ensuring results are scientifically sound, timely, and defensible. The Senior Microbiologist works closely with internal technical teams and external client partners and contributes directly to maintaining the high standards of quality and reliability that Element is known  this role, you'll lead scientifically challenging projects, partner directly with clients, and contribute to studies that support product development, regulatory compliance, and patient safety.

• Design and execute custom microbiological studies to address Client objectives and regulatory requirements.
• Lead and execute antimicrobial efficacy testing programs using both standard and customized methodologies.
• Lead reusable medical device validation studies, including cleaning, high-level disinfection, and sterilization validations.
• Perform and oversee microbiological testing including:
  • Cleaning validation testing
  • Disinfection validation testing (Low Level, Intermediate Level, and High Level)
  • Sterilization validation testing
  • Bioburden testing
  • Sterility testing
  • Endotoxin testing
  • Microbial enumeration
  • Organism identification
  • Microbial limits testing
  • Environmental monitoring
  • Cleanroom qualification activities
• Design, develop, qualify, verify, and validate microbiological methods in accordance with applicable industry standards and regulatory expectations.
• Collaborate directly with clients to understand project objectives and develop scientifically sound testing strategies.
• Analyze and interpret microbiological data and prepare clear, accurate technical reports.
• Review protocols, raw data, laboratory records, and final reports to ensure scientific quality and regulatory compliance.
• Support research and development initiatives aimed at expanding laboratory capabilities and introducing new testing methodologies.
• Troubleshoot complex technical challenges and implement practical scientific solutions.
• Serve as a technical resource and mentor for laboratory staff.
• Maintain compliance with cGLP, ISO 17025, and Element quality system requirements.

• BS or MS in Microbiology, Biology, Medical Laboratory Science, or related scientific discipline.
• 5+ years of microbiology experience in a cGLP, ISO 17025, FDA-regulated, medical device, pharmaceutical, or contract testing environment.
• Demonstrated experience with reusable medical device testing, including cleaning, disinfection, sterilization validation, or related studies.
• Experience performing antimicrobial efficacy testing and microbiological method development preferred.
• Working knowledge of USP , , , , , , and related microbiological standards.
• Familiarity with FDA, ISO, ASTM, AOAC, and AAMI standards is highly desirable.
• Strong understanding of aseptic technique, contamination control, and laboratory best practices.
• Excellent analytical, technical writing, and problem-solving skills.
• Ability to manage multiple projects and priorities while maintaining high standards of quality and compliance.
• Strong communication skills with the ability to interact effectively with clients, auditors, and internal teams.

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