Senior Microbiologist: Cleanroom Risk & Validation Lead

MiniMed Group; California (MO); Hybrid; USD 87,000 - 165,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits (health, dental

401(k) with company match

Job summary

MiniMed is seeking a Senior Microbiologist to lead lot release testing and validation development on-site in Northridge, CA. The role emphasizes microbiology expertise, disinfection strategies, and risk management for cleanroom environments.

The candidate will collaborate across product development, manufacturing, and sustaining engineering, and will author protocols, assessments, and regulatory submissions while overseeing external labs and audits.

Qualifications

• Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities

• Serve as SME for microbiology, microbial control, disinfection, and contamination risk management.
• Develop and execute microbiological strategies across development, manufacturing, and cleanroom environments.
• Lead microbiological risk assessments for products, processes, materials, and cleanrooms.
• Establish acceptance criteria, sampling plans, and test methods for environmental monitoring.
• Develop and validate cleaning, disinfection, and microbial-control processes.
• Author and review protocols, reports, specifications, SOPs, and regulatory submissions.
• Evaluate microbiological results, trends, deviations, and investigations with CAPAs.
• Provide microbiology input for design controls, hazard analyses, and supplier issues.
• Qualify and oversee external microbiology laboratories and audits.

Skills

Microbiology expertise

Risk assessment

Environmental monitoring

Data analysis

Regulatory submissions support

Education

Bachelor's degree in Microbiology or related field

Advanced degree (MS/PhD) in Microbiology or related field

Job description

MiniMed is seeking a Senior Microbiologist to lead lot release testing and validation development on-site in Northridge, CA. The role emphasizes microbiology expertise, disinfection strategies, and risk management for cleanroom environments.

The candidate will collaborate across product development, manufacturing, and sustaining engineering, and will author protocols, assessments, and regulatory submissions while overseeing external labs and audits.