Microbiologist I
The Microbiologist I at Confidential Client supports microbiological quality assurance in medical device manufacturing by applying microbiological concepts to process monitoring and sterilization validation. This entry-level role involves conducting routine testing, data analysis, documentation, and training, ensuring compliance with FDA regulations and quality management systems. The position requires collaboration across teams to maintain high standards of microbiological quality and support continuous improvement initiatives.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
This entry-level Microbiologist I role supports microbiological quality for medical device manufacturing. You will learn and apply microbiological principles across manufacturing, testing, qualification, and documentation tasks.
- Provide microbiological support: review routine microbiological test results and provide technical support for sterilization, environmental monitoring, and microbiological methods.
- Lead or support routine out-of-specification (OOS) investigations and data analysis for sterilization processes.
- Develop and execute qualifications for controlled access environments, deionized water systems, and compressed air systems.
- Assess manufacturing process changes for potential microbial impact and recommend mitigations.
- Write, update, and maintain microbiology-related documentation including protocols, validation reports, environmental disturbance reports, LAL risk assessments, and annual controlled environment reports.
- Create and execute validation protocols for sterilization and microbiological test methods; perform or oversee validations for new technologies, equipment, and test methods.
- Provide technical training to laboratory technicians on new equipment, procedures, sterilization validation, and sterilization process fundamentals.
- Support Quality Management System (QMS) and Environmental Management System (EMS) initiatives; ensure compliance with FDA and other applicable regulatory requirements.
- Collaborate across functions — manufacturing, quality, engineering, and suppliers — to drive timely resolution of microbiological issues and continuous improvement projects.
Responsibilities & Day-to-Day
- Review and interpret microbiological data; document findings and follow-up actions.
- Perform sample review and trend analysis for environmental monitoring programs.
- Support routine lab activities and maintain documentation linkage and audit readiness.
- Participate in cross-functional teams for process improvement and product quality initiatives.
- Maintain positive, cooperative working relationships with internal and external stakeholders.
Required Qualifications
- Bachelor’s degree in Microbiology or a related life science, or equivalent combination of education and experience.
- Minimum 2 years of experience in microbiology or sterilization within medical device, pharmaceutical, food, or other FDA-regulated industries.
- Understanding of environmental monitoring, sterilization principles, and basic microbiological methods.
- Strong written and verbal communication skills; ability to write protocols and technical reports.
- Able to work with minimal supervision, manage priorities, and meet deadlines.
- Comfortable working in a matrixed, geographically dispersed organization and collaborating across teams.
- Strong organizational skills, attention to detail, and follow-through.
- Willingness to travel approximately 5–10%, including occasional international travel.
Preferred Qualifications
- Experience with sterilization validations and sterilization process data analysis.
- Experience with controlled access environment qualifications, water systems, or compressed air systems.
- Familiarity with QMS/EMS systems and regulatory requirements (FDA).
- Previous experience training lab personnel and writing technical protocols.
Compensation & Benefits
- Base pay range: $50,700 – $101,300 per year (base). In specific locations the pay range may vary.
- Competitive benefits typically include medical coverage, retirement savings/401(k) contributions, tuition assistance programs, and professional development opportunities.
- Reasonable accommodations are available for qualified applicants with disabilities.
Location & Work Schedule
- This is an on-site role based in Hamel / Plymouth area, MN and follows typical business hours. Candidates must be able to maintain regular and predictable attendance.
Why Apply Through Careertakes
- Careertakes is a third-party recruiting platform that connects qualified candidates with Confidential Client opportunities in Scientific & QA. If selected, you’ll be employed directly by our client and may receive access to additional matched roles via the Careertakes platform.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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