Microbiologist

Overview

The Microbiology & Sterilization Specialist will support integration, remediation, and sustainment activities related to sterilization, microbiology, and environmental control processes. This role is responsible for assessing current practices, updating procedures, and ensuring compliance with applicable standards and regulatory requirements. The specialist will collaborate with cross‑functional teams to maintain robust sterilization and microbiological control programs that uphold product quality and patient safety.

This project is slated to continue through February 2027.

• Conduct updated gap assessments of existing microbiology and sterilization processes, procedures, and controls.
• Identify deficiencies and develop remediation plans to align with regulatory expectations and industry standards.
• Update, revise, and improve procedures related to sterilization, microbiological testing, and environmental monitoring.
• Serve as a steward for the enforcement and implementation of relevant standards and regulations within the Quality and Sterilization domains.
• Ensure alignment with ISO 11135 (EO sterilization), FDA regulations, GMP requirements, and internal quality system procedures.
• Support routine GQO activities related to sterilization oversight and environmental control programs.
• Provide technical guidance on bioburden, endotoxin testing, and environmental monitoring practices.
• Support cleanroom operations, sterilization validation activities (IQ/OQ/PQ), and ongoing compliance initiatives.
• Collaborate with cross‑functional partners to ensure consistent application of microbiological and sterilization best practices.

• Minimum 3 years of experience in EO sterilization or microbiology within the medical device or pharmaceutical industry.
• Hands‑on experience with sterilization validation (IQ/OQ/PQ), cleanroom operations, and regulatory compliance.
• Demonstrated ability to assess and remediate sterilization or microbiological processes.

• ISO 11135 requirements for ethylene oxide (EO) sterilization.
• FDA and GMP regulatory frameworks applicable to sterilization and microbiology.
• Working knowledge of bioburden testing, endotoxin testing, and environmental monitoring programs.
• Strong analytical and critical thinking abilities.
• Ability to manage and prioritize multiple projects simultaneously.
• Effective verbal and written communication skills.
• Detail‑oriented, organized, and capable of working independently with minimal supervision.
• Collaborative mindset with the ability to work across functions.

The role involves working in a laboratory setting with a focus on sterilization and microbiological processes. The environment requires adherence to cleanroom and regulatory compliance protocols.

This is a Contract position based out of Irvine, CA.

The pay range for this position is $40.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:
This is an onsite position in Irvine, CA. Final date to receive applications:
This position is anticipated to close on Feb 10, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.