Microbiologist

Job Title: Sr MicrobiologistDuration: 12 Months (Possible extension/hire)Location: Arden Hills, MN 55112 (Hybrid Role - 3 days onsite)Shift: Business 1st Shift (8:00 AM – 4:30 PM)Position SummarySenior Microbiologist to provide technical support for contract manufactured devices, acquisition activities, new product development projects, microbiological risk assessments, and quality system activities across the organization.This position will serve as a microbiology subject matter expert (SME), partnering with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external business partners to evaluate microbiological risks, support investigations, assess product and process changes, and ensure compliance with applicable quality system requirements.The successful candidate will operate in a highly collaborative environment, providing scientific expertise and risk-based decision making to support product quality, patient safety, and regulatory compliance.Key ResponsibilitiesServe as a microbiology SME supporting contract manufactured devices and external manufacturing partnersSupport acquisition due diligence activities, product integration efforts, and manufacturing transfer initiativesPerform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changesAuthor and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentationEvaluate microbiological impact associated with product, process, material, supplier, and facility changesSupport investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertisePartner with cross-functional teams to assess microbiological considerations related to manufacturing, design changes, commercialization activities, and supplier controlsProvide microbiology support for new product development projects and product lifecycle management activitiesParticipate in audits, inspections, and regulatory readiness activities as neededSupport continuous improvement initiatives and implementation of microbiology-related quality system enhancementsCommunicate microbiological risks, recommendations, and technical rationale to stakeholders across multiple functions and geographic regionsMinimum QualificationsMinimum of five (5) years of experience in microbiology, quality, manufacturing, engineering, or related technical functions within a regulated industryExperience performing scientific evaluations and technical risk assessmentsStrong technical writing and documentation skillsAbility to independently manage multiple projects and prioritiesStrong communication and stakeholder management skillsBachelor's degree in Microbiology, Biology, Biomedical Sciences, or a related scientific disciplinePreferred QualificationsMedical device industry experience strongly preferredExperience supporting contract manufactured products or external manufacturing partnersExperience supporting acquisitions, manufacturing transfers, or product transfer activitiesKnowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principlesExperience supporting CAPA, investigations, nonconformance management, and change management activitiesFamiliarity with FDA regulations, ISO 13485, and other applicable global quality system requirementsExperience working in cross-functional and global project teamsExperience presenting technical recommendations to leadership and project teamsDesired CompetenciesStrong scientific and technical problem-solving skillsRisk-based decision-making capabilityAbility to influence stakeholders through scientific rationaleExcellent written and verbal communication skillsStrong organizational and project management abilitiesAbility to work effectively across multiple functions, sites, and geographic regionsTravelApproximately 10-20% travel may be required to support site activities, audits, acquisitions, manufacturing transfers, project teams, and business needs.