Senior Microbiologist – Quality & Manufacturing SME

Veterans Sourcing Group, LLC; Saint Paul (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Veterans Sourcing Group, LLC in Minnesota is seeking a Senior Microbiologist to provide technical support for contract manufactured devices, risk assessments, and quality system activities. The SME will collaborate with Manufacturing, Quality, Regulatory Affairs, Research & Development, and external partners to evaluate microbiological risks and ensure patient safety and regulatory compliance.

The role requires strong technical writing, project management, and ability to lead investigations,

Qualifications

• Five+ years of microbiology/quality/manufacturing experience in a regulated environment.
• Experience performing scientific evaluations and risk assessments.
• Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or related field.

Responsibilities

• Serve as a microbiology SME supporting contract manufactured devices and external manufacturing partners.
• Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes.
• Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation.
• Evaluate microbiological impact associated with product, process, material, supplier, and facility changes.
• Support investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertise.
• Partner with cross-functional teams to assess microbiological considerations related to manufacturing, design changes, commercialization activities, and supplier controls.
• Provide microbiology support for new product development projects and product lifecycle management activities.
• Participate in audits, inspections, and regulatory readiness activities as needed.
• Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements.
• Communicate microbiological risks, recommendations, and technical rationale to stakeholders across multiple functions and geographic regions.

Skills

Scientific writing

Communication skills

Project management

Stakeholder management

Education

Bachelor's degree in Microbiology

Job description

Veterans Sourcing Group, LLC in Minnesota is seeking a Senior Microbiologist to provide technical support for contract manufactured devices, risk assessments, and quality system activities. The SME will collaborate with Manufacturing, Quality, Regulatory Affairs, Research & Development, and external partners to evaluate microbiological risks and ensure patient safety and regulatory compliance.

The role requires strong technical writing, project management, and ability to lead investigations,