Senior Microbiologist: cGLP/ISO 17025 Lead

Element Materials Technology; Eagan (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Element Materials Technology in Eagan, MN seeks a Senior Microbiologist to join our microbiological testing and analytical support lab serving antimicrobial, pharmaceutical, medical device, and related regulated manufacturing sectors. You will design and execute studies, lead validation efforts, and ensure data integrity in a cGLP/ISO 17025 environment.

You will mentor staff, collaborate with clients, review data and reports, and help expand capabilities with new methods, aligning with

Qualifications

• 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 <61>, <62>, <71>, <85>, <1116>, <797>, and related microbiological standards.

Responsibilities

• 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, disinfection validation, sterilization validation, bioburden testing, sterility testing, endotoxin testing, microbial enumeration, organism identification, microbial limits testing, environmental monitoring, and 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 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.

Skills

Microbiology

Regulatory knowledge

Aseptic technique

Technical writing

Data analysis

Client communication

Project management

Education

BS or MS in Microbiology

Job description

Element Materials Technology in Eagan, MN seeks a Senior Microbiologist to join our microbiological testing and analytical support lab serving antimicrobial, pharmaceutical, medical device, and related regulated manufacturing sectors. You will design and execute studies, lead validation efforts, and ensure data integrity in a cGLP/ISO 17025 environment.

You will mentor staff, collaborate with clients, review data and reports, and help expand capabilities with new methods, aligning with