Senior Microbiologist - Hybrid Quality & Risk Leader

Advantage Technical; Arden Hills (MN); Hybrid; USD 67,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

Health Savings Account (HSA)

AD&D Insurance

Job summary

Advantage Technical is hiring a Senior Microbiologist in Arden Hills, MN (Hybrid). This role focuses on product quality, risk assessments, and lifecycle support within a regulated manufacturing environment.

You will collaborate with Quality, Manufacturing, Regulatory Affairs, and Engineering, leading risk assessments, documenting technical reports, and driving CAPA and change management initiatives to ensure compliance and product safety.

Qualifications

• Bachelor's degree required in Microbiology, Biology, Biomedical Sciences, or related field.
• 5+ years of microbiology experience in a regulated industry.
• Experience with risk assessments, technical documentation, and quality systems.
• Strong communication, project management, and problem-solving skills.
• Medical device or highly regulated manufacturing experience preferred.
• Knowledge of contamination control, environmental monitoring, bioburden, sterilization, CAPA, and FDA/ISO quality requirements is a plus.

Responsibilities

• Conduct microbiological risk assessments for products, materials, suppliers, facilities, and manufacturing processes.
• Review and author technical reports, risk assessments, and scientific documentation.
• Support investigations, CAPA activities, nonconformance reviews, and change management initiatives.
• Provide microbiology expertise for new product development and product lifecycle projects.
• Evaluate microbiological impact of manufacturing, material, supplier, and facility changes.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, Engineering, and external partners.
• Support audits, inspections, manufacturing transfers, and continuous improvement initiatives.

Education

Bachelor's degree in Microbiology, Biology, Biomedical Sciences, or related field

Job description

Advantage Technical is hiring a Senior Microbiologist in Arden Hills, MN (Hybrid). This role focuses on product quality, risk assessments, and lifecycle support within a regulated manufacturing environment.

You will collaborate with Quality, Manufacturing, Regulatory Affairs, and Engineering, leading risk assessments, documenting technical reports, and driving CAPA and change management initiatives to ensure compliance and product safety.