Manager, Microbiologist- Sterilization

5+ years

$112,000.00 - $168,000.00

California

10 April 29, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Microbiologist – Sterilization
Location: Northridge, California, United States
Job ID: R26449
Time Type: Full Time
Application Deadline: May 9, 2025

About Medtronic:
Medtronic is a global leader in healthcare technology, uniting over 95,000 employees in our mission to alleviate pain, restore health, and extend life. With innovation at our core, we engineer groundbreaking solutions that impact lives every day.

Position Summary:
We are seeking an experienced and driven Microbiologist – Sterilization Manager to lead the Environmental Monitoring team at our Northridge, CA facility (100% on-site). You will oversee contamination control programs for cleanrooms used in the manufacturing of terminally sterilized medical devices. This is a hands-on role with a strong emphasis on risk-based strategies and regulatory compliance.

Key Responsibilities:

Develop and implement cleanroom contamination control programs per ISO and EN standards.
Perform qualifications/requalifications of cleanroom environments.
Collaborate cross-functionally on new/modified cleanroom projects, developing risk-based validation plans.
Develop and monitor key environmental metrics and escalate deviations.
Investigate contamination events and drive CAPAs.
Conduct microbiological testing on raw materials, in-process, and finished products.
Manage and qualify laboratory equipment.
Develop/validate microbiological and cleaning methods for equipment and environments.
Ensure compliance with regulatory protocols and GMP/GLP standards.
May contribute to method transfers from R&D to production.

Must-Have Qualifications:

Bachelor’s Degree in microbiology, biotechnology, or related field with 5+ years of relevant cleanroom experience OR
Advanced Degree with 3+ years of experience in contamination control standards (e.g., ISO 14644, ISO 14698, EN 17141).

Preferred Qualifications:

Strong leadership and interpersonal skills.
Proficient in technical writing and documentation.
Deep knowledge of cGMP, cleanroom practices, and laboratory environments.
Experience with cleanroom utilities (e.g., HVAC, purified water, compressed gases).
Expertise in sterilization methods: ethylene oxide, radiation, moist heat.
Familiarity with microbiological methods like bioburden, endotoxin, and membrane filtration.
Experience with developing cleaning methods for equipment.

Work Conditions & Physical Requirements:

Regular use of computer and mobility within the facility.
Must be able to comply with physical demands required to maintain sterile environments.
Reasonable accommodations will be made for individuals with disabilities.

Compensation & Benefits:

Salary Range: $112,000 – $168,000 (USD)
Incentives: Medtronic Incentive Plan (MIP) eligible
Benefits Include:
- Health, dental, vision insurance
- 401(k) with match
- Life & disability insurance
- Tuition assistance
- Employee Stock Purchase Plan
- Paid holidays, PTO, and more

Note: Compensation and benefits may vary based on geographic location and experience.

Equal Opportunity Employer Statement:
Medtronic is an equal opportunity employer committed to diversity and inclusion. We provide equal employment opportunities to all applicants and employees and make reasonable accommodations for qualified individuals with disabilities.

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Manager, Microbiologist- Sterilization

Job Description

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