Senior Microbiologist

MiniMed•Los Angeles, CA

7d•$97,000 - $165,000•Onsite

About The Position

We are looking for a dynamic Senior Microbiologist to join our team and support critical lot release testing and validation development and execution. This role is full time on-site in Northridge, CA. Serve as subject matter expert for microbiology, microbial control, disinfection, and contamination risk management. Develop and execute microbiological strategies across product development, manufacturing, sustaining engineering, and for existing and future cleanroom environments. Lead microbiological risk assessments for products, processes, materials, and cleanroom environments. Establish acceptance criteria, sampling plans, and test methods for the environmental monitoring program. Develop and execute validation of cleaning, disinfection, and microbial-control processes. Author and review protocols, reports, specifications, SOPs, and regulatory submission content. Evaluate microbiological results — including trends, deviations, and OOS/OOC findings — and own investigations and corrective actions. Provide microbiology input for design controls, hazard analyses, change controls, CAPAs, complaints, risk assessment, and supplier issues. Qualify and oversee external microbiology laboratories, including method review, data assessment, and participation in laboratory audits.

Requirements

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 subject matter expert for microbiology, microbial control, disinfection, and contamination risk management.
Develop and execute microbiological strategies across product development, manufacturing, sustaining engineering, and for existing and future cleanroom environments.
Lead microbiological risk assessments for products, processes, materials, and cleanroom environments.
Establish acceptance criteria, sampling plans, and test methods for the environmental monitoring program.
Develop and execute validation of cleaning, disinfection, and microbial-control processes.
Author and review protocols, reports, specifications, SOPs, and regulatory submission content.
Evaluate microbiological results — including trends, deviations, and OOS/OOC findings — and own investigations and corrective actions.
Provide microbiology input for design controls, hazard analyses, change controls, CAPAs, complaints, risk assessment, and supplier issues.
Qualify and oversee external microbiology laboratories, including method review, data assessment, and participation in laboratory audits.