TÜV SÜD America

Microbiologist

New Brighton, MN
Full Time
PS-MHS
Experienced

With a legacy spanning over 150 years, TÜV SÜD is a global leader in technical services, employing over 25,000 professionals across 1,000 offices worldwide. For more than 30 years, TÜV SÜD America has been committed to advancing safety, sustainability, and innovation across 33 locations. Dedicated to protecting people, property, and the environment from technology-related risks, we drive consumer protection, digital transformation, and sustainable development.

TÜV SÜD’s Medical Device Testing Lab located in New Brighton MN, specializes in medical device and packaging testing, offering a comprehensive, one-stop solution for manufacturers. Our lab consists of four specialized disciplines—Biocompatibility, Chemistry, Microbiology, and Packaging—ensuring excellence in medical device evaluation. It is a part of a greater global network of Medical Device testing labs.

Position Summary:
TÜV SÜD is seeking a knowledgeable Microbiologist who will provide support to the Medical Device Test laboratory team, performing microbiology-based studies/testing and evaluating a variety of medical devices. Laboratory Test Methods include those for Sterility Assurance (i.e., bioburden, sterility, endotoxin testing, etc.) and Cleaning, Disinfection, and Sterilization Validation Studies for Reusable Devices. The ideal candidate has a strong laboratory background, as well as excellent project management skills and attention to detail.

Responsibilities:

- Performs microbiology testing, including but not limited to reusable device testing, bioburden, sterility, endotoxin, biological indicators, etc.

- Conducts microbiology lab support tasks such as media preparation, sample preparation, instrument calibrations, and microbial testing.

- Provides scientific support and guidance to scientific staff and management in execution and interpretation of test records to ensure technical integrity of studies.

- Ensure adherence to testing submission forms, protocols, protocol amendments, and company SOPs throughout the conduct of studies/testing.

- Accurately analyze, record, organize, and communicate all data, including unanticipated responses and nonconforming work.

- Reports clear and concise updates and results to laboratory management.

- Works effectively with minimal supervision.

- Prioritizes and executes daily project tasks and reports test results in a timely manner according to performance metrics.

- Collaborates and clearly communicates with Team Lead and cross-functional teams to ensure client needs are met.

- Maintains and analyzes ancillary records (logbooks, worksheets) according to protocols, SOPs, and other regulations.

- Lead and support planning and execution of equipment/instrument qualification, validation, and calibration.

- Assists Team Leads, Project Managers, Technical Advisors, and other biological team members in establishing test recommendations according to microbiology industry guidelines/standards including, but not limited to: ISO 11737, USP <71>, USP <61>, ANSI/AAMI ST72,  USP <85>, USP <161>, ISO 14698, ISO 17664, AAMI TIR30, ASTM F3438, ISO 11135, ISO 11137.

- Contributes to continual improvements of the laboratory quality system, compliance, and laboratory support.

- Provides support and lead in laboratory method development by assisting with generating new documents, creating document revisions, and providing technical review of documents.

- Other duties as assigned by management.

Qualification

- Minimum BS/BA in biology or related scientific field.

- Minimum of 4 years of applicable experience in a laboratory environment. Preferred experience with medical device reprocessing validations, sterility testing, sterilization (EO, Steam, Dry Heat, Gamma), bioburden, and endotoxin testing

- Medical device, preclinical, or pharmaceutical laboratory experience.

- Knowledge in Study Directing is desired, but not a requirement

Specific Skills, Knowledge and Abilities: 

- Experience in aseptic technique and work with biological cell lines and/or microorganisms

- Experience operating within quality system requirements or regulated environment

- Strong problem-solving, analytical and organizational skills

- Exhibit excellent written and oral communication skills and be a proactive, collaborative team player

- Ability to function independently and within a team environment

- Ability to organize and track multiple projects in a detail-oriented and self-directed manner

- Self-starter with a positive and motivated attitude

- Good working knowledge of industry regulations supporting a medical device environment

- Experience with Microsoft Office (Word, Excel, PowerPoint, Teams, Outlook, etc.)

Fundamental competencies form the foundation for individual and organizational success in TÜV SÜD and apply to all employees and showcase behaviors aligned to TÜV SÜD values and culture cornerstones and will be evaluated in performance assessments.:

- Communication

- Collaboration

- Customer Orientation

- Self Management

Additional information

This full-time position's anticipated annual base pay range is $70,000-$80,000. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target, subject to eligibility and other requirements. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, 12 weeks of paid parental leave, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.

Equal Opportunity Employer – Disability and Veteran

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following: Labor Law 2025

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