Senior Microbiologist — Devices, Risk & QA Leadership

Canon Recruiting Group; Saint Paul (MN); Hybrid; USD 63,000 - 89,000; Full time

Benefits offered by this job

Health care

401(k) savings plans

Job summary

Canon Recruiting Group in Arden Hills, MN is seeking a Senior Microbiologist IV for a 12-month assignment. The role offers hybrid work with 8am-4:30pm schedule and approximately 10-20% travel to support site activities and audits.

The Senior Microbiologist will provide technical microbiology support for contract manufactured devices, assist with due diligence, risk assessments, and quality system activities, partnering across Manufacturing, Quality, Regulatory Affairs, and R&D to ensure product

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum of five (5) years of experience in microbiology or related functions within a regulated industry.
• Strong technical writing and documentation skills.

Responsibilities

• Serve as microbiology SME supporting contract manufactured devices and external manufacturing partners.
• Support acquisition due diligence activities, product integration efforts, and manufacturing transfer initiatives.
• 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.

Skills

Strong communication

Technical writing

Project management

Risk assessment

Education

Bachelor's degree in Microbiology or related field

Job description

Canon Recruiting Group in Arden Hills, MN is seeking a Senior Microbiologist IV for a 12-month assignment. The role offers hybrid work with 8am-4:30pm schedule and approximately 10-20% travel to support site activities and audits.

The Senior Microbiologist will provide technical microbiology support for contract manufactured devices, assist with due diligence, risk assessments, and quality system activities, partnering across Manufacturing, Quality, Regulatory Affairs, and R&D to ensure product