Senior Microbiologist

Sr. Microbiologist Sterilization and Quality SystemsHybrid Schedule | Long-term Growth | Offers BenefitsThis Sr. Microbiologist role provides technical leadership and oversight for sterilization department objectives and corporate microbiology and sterilization strategies across a regulated manufacturing environment. You will serve as a microbiology subject matter expert, partnering closely with Manufacturing, Quality, Supplier Quality, Regulatory Affairs, Research & Development, and external business partners to evaluate microbiological risks, support investigations, guide product and process changes, and ensure alignment with applicable quality system requirements. Operating in a highly collaborative setting, you will use scientific expertise and risk-based decision making to support product quality, patient safety, and regulatory compliance for existing and new products, including contract manufactured devices and acquisition-related activities.ResponsibilitiesManage assigned Sterilization Department projects, ensuring effective planning, execution, and documentation in support of product quality and regulatory compliance.Review regulatory documentation for design dossier submissions and Pre-Market Approval submissions, ensuring sterilization strategies and microbiological controls are appropriately justified and clearly presented.Develop and author sterilization-related responses to questions posed by regulatory bodies and notified organizations, providing clear scientific rationale and risk-based explanations.Set direction for activities that minimize regulatory exposure related to product sterilization during development and manufacturing, and actively participate in regulatory groups to ensure sterilization requirements are accurately conveyed.Consolidate and analyze questions received from regulatory agents across manufacturing sites, and translate these into corporate guidance that informs the writing of design dossiers and pre-market approvals.Act as a corporate resource for sterilization services, reviewing sterilization process validation and product qualification documentation for multiple divisions and ensuring consistency with internal standards and global regulations.Research, review, and interpret sterilization studies and objectives associated with new equipment development, providing recommendations to optimize microbiological safety and process robustness.Work directly with notified bodies to convey sterilization strategies, including delivering training, setting priorities, and resolving day-to-day issues related to sterilization and microbiological controls.Participate in the development and writing of international standards for sterilization technologies, contributing subject matter expertise to influence industry best practices.Consult on sterilization and quality issues, support problem solving and resolution, and provide guidance to internal and external customers for sterilization testing and microbiological evaluation needs.Serve as a microbiology subject matter expert supporting contract manufactured devices and external manufacturing partners, ensuring appropriate microbiological controls and sterilization validation.Support acquisition due diligence activities by assessing microbiological and sterilization risks, and contribute to product integration and manufacturing transfer initiatives.Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes, and document risk-based conclusions and recommendations.Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation that underpin product claims and regulatory submissions.Evaluate the microbiological impact of product, process, material, supplier, and facility changes, and recommend appropriate controls, validations, and mitigations.Support investigations, nonconformances, corrective and preventive actions (CAPAs), and other quality system activities that require microbiology expertise, ensuring thorough root cause analysis and effective remediation.Partner with cross-functional teams to assess microbiological considerations related to manufacturing operations, design changes, commercialization activities, and supplier controls.Provide microbiology support for new product development projects and product lifecycle management activities, ensuring sterilization and contamination control requirements are integrated from concept through commercialization.Participate in audits, inspections, and regulatory readiness activities, representing microbiology and sterilization functions and supporting responses to regulatory and customer inquiries.Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements, driving standardization and robustness across sites and regions.Communicate microbiological risks, recommendations, and technical rationale clearly to stakeholders across multiple functions and geographic regions, influencing decisions through sound scientific reasoning.Independently manage multiple projects and priorities, ensuring timely completion of deliverables and effective coordination with global and cross-functional project teams.Travel approximately 10-20% as needed to support site activities, audits, acquisitions, manufacturing transfers, project teams, and other business needs.RequirementsBS with 9-13yrs experience, MS with 7-11yrs experience, PhD with 4-8yrs experience.Demonstrated experience performing scientific evaluations and technical risk assessments, particularly in microbiology and sterilization contexts.Strong technical writing and documentation skills, including the ability to author and review scientific reports, regulatory documentation, and risk assessments.Proven ability to independently manage multiple projects and priorities in a dynamic environment.Strong communication skills with the ability to convey complex microbiological and sterilization concepts to diverse stakeholders.Effective stakeholder management capabilities, including collaboration with cross-functional and global teams.Solid understanding of quality systems within regulated industries and how microbiology and sterilization requirements integrate into those systems.Additional Skills & QualificationsMedical device industry experience is strongly preferred, particularly in roles involving sterilization and microbiological controls.Experience supporting contract manufactured products or external manufacturing partners, including evaluation of their microbiological and sterilization practices.Experience supporting acquisitions, manufacturing transfers, or product transfer activities, with emphasis on assessing and integrating microbiological and sterilization requirements.Knowledge of contamination control, environmental monitoring, bioburden, sterilization processes, and microbiological risk assessment principles.Experience supporting CAPA, investigations, nonconformance management, and change management activities within a quality system framework.Familiarity with FDA regulations and other applicable global quality system requirements relevant to medical products and sterilization.Experience working in cross-functional and global project teams, contributing microbiology expertise to complex, multi-site initiatives.Experience presenting technical recommendations and microbiological risk assessments to leadership and project teams.Strong scientific and technical problem-solving skills, with the ability to analyze complex data and propose practical, risk-based solutions.Demonstrated risk-based decision-making capability, using scientific evidence and regulatory expectations to guide recommendations.Ability to influence stakeholders through clear scientific rationale and well-supported technical arguments.Excellent written and verbal communication skills, tailored to both technical and non-technical audiences.Strong organizational and project management abilities, including planning, prioritization, and follow-through.Ability to work effectively across multiple functions, sites, and geographic regions, building collaborative relationships and aligning on microbiology and sterilization strategies.Work EnvironmentThis position is based in a hybrid work environment, combining on-site presence with remote work flexibility as aligned with business and project needs. The primary location is in Arden Hills, MN, operating on a first shift schedule typically from 8:00 a.m. to 4:30 p.m. You will work closely with manufacturing, quality, regulatory, and R&D teams in a regulated setting that emphasizes product quality, patient safety, and compliance with global standards. The role involves approximately 10-20% travel to manufacturing sites, partner locations, and other facilities to support audits, acquisitions, manufacturing transfers, and project activities. The culture values collaboration, scientific rigor, continuous improvement, and cross-functional engagement, providing opportunities to contribute to international standards, global initiatives, and complex technical challenges.