Microbiologist Iv

Job Title: Microbiologist IV

Company: Novozen Health Care

Location: Arden Hills, MN (Hybrid)

Employment Type: Contract 12 Months (Extendable)

• Serve as a microbiology subject matter expert (SME) supporting contract-manufactured medical devices and external manufacturing partners.

• Support acquisition due diligence, product integration, manufacturing transfers, and new product development initiatives.

• Conduct microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes.

• Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and scientific documentation.

• Evaluate microbiological impacts associated with product, process, material, supplier, and facility changes.

• Support investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertise.

• Collaborate with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external partners.

• Provide microbiology support for product development, commercialization, and product lifecycle management activities.

• Participate in audits, inspections, and regulatory readiness activities as required.

• Support continuous improvement initiatives and microbiology-related quality system enhancements.

• Communicate microbiological risks, technical recommendations, and scientific rationale to cross-functional stakeholders.

• Travel approximately 10 20% as needed for site activities, audits, acquisitions, and manufacturing transfer initiatives.

• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific discipline.

• Minimum of 5 years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industry.

• Experience performing scientific evaluations and technical risk assessments.

• Strong technical writing, documentation, communication, and stakeholder management skills.

• Ability to independently manage multiple projects and priorities.

Preferred Qualifications:

• Medical device industry experience.

• Experience supporting contract-manufactured products and external manufacturing partners.

• Experience with acquisitions, manufacturing transfers, or product transfer activities.

• Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.

• Experience with CAPA, investigations, nonconformance management, and change management.

• Familiarity with FDA regulations, ISO 13485, and applicable global quality system requirements.

• Experience working with cross-functional and global project teams.

• Strong scientific problem-solving, risk-based decision-making, and project management skills.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.