Company: Novozen Health Care
Location: Arden Hills, MN (Hybrid)
Employment Type: Contract 12 Months (Extendable)
Job ResponsibilitiesServe 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.
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