Senior Microbiologist

Sr. Microbiologist Sterilization and Quality Systems

Hybrid Schedule | Long-term Growth | Offers Benefits

This 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.

Responsibilities

• Manage 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.

Requirements

• BS 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 & Qualifications

• Medical 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 Environment

This 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.