Quality Engineer - Microbiology

Quality Engineer - Microbiology

Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. Performs validation, technology transfer, and troubleshooting. Writes policy procedures for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.

Responsibilities

• Coordinate microbiological and/or chemical testing.
• Release product and test for validation protocols.
• Perform organism identification.
• Perform technical review of batch filling records to ensure quality of aseptic processes.
• Read and interpret microbiological cultures and other related tests including environmental monitoring, sterility tests, growth promotion, microbial limits tests, and antimicrobial effectiveness tests.
• Perform validation, technology transfer, and troubleshooting.
• Write policy procedures for quality initiatives.
• Review and approve environmental monitoring data and laboratory equipment and records.
• Prepare process and status reports.
• Assign and monitor document numbers and review documents for accuracy and completeness.

Essential Skills

• Quality engineering
• Cleanroom monitoring
• Sterilization process
• Equipment requalification
• Medical device quality control
• Microbiology

Additional Skills & Qualifications

• Bachelor of Science, Engineering or related subject with 3-5 years' experience in a quality or technical discipline
• Ability to work independently with minimal supervision
• Judgment in applying professional expertise
• Understanding and application of procedures and concepts of own discipline

Work Environment

This is an individual contributor role that requires minimal supervision. The work requires a university degree or extensive practical knowledge gained through experience. The role involves making judgments based on practice and previous experience. Benefits include 2 weeks of PTO and 10 paid holidays.

Pay and Benefits

The pay range for this position is $35.00 - $42.00/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 the following: 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 a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on May 9, 2025.

About Actalent

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 actALENTaccommodation@actalentservices.com for other accommodation options.