Microbiologist III - 2nd Shift

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 60,614 - 66,124; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance

401K

Job summary

Alliance Medical Products, Inc. is seeking a Microbiologist III for the 2nd shift (2:00 PM – 10:30 PM) in Irvine, California. This role involves executing microbiological tests, overseeing validations, and supporting aseptic operations in a GMP environment.

Candidates should have a Bachelor's degree in Microbiology and 8-10 years of relevant experience. Strong technical skills and the ability to work cross-functionally are essential. The position offers an hourly pay range of $44–48 plus benefits.

Qualifications

• 8-10 years of experience in a pharmaceutical microbiology laboratory.
• Experience executing microbiological method qualification/validation.
• GMP pharmaceutical experience required.

Responsibilities

• Perform and oversee microbiological testing of materials and products.
• Manage microbiological method qualifications and validations.
• Support aseptic operations and environmental monitoring.

Skills

Pharmaceutical microbiological testing

Aseptic processing principles

Technical problem-solving

GMP requirements understanding

Communication skills

Organizational skills

Computer applications proficiency

Laboratory safety knowledge

Education

Bachelor's degree in Microbiology or closely related discipline

Tools

LIMS

MS Word

Excel

Job description

Microbiologist III – 2nd Shift (2:00 PM – 10:30 PM)

The Microbiologist III is a senior individual contributor in the Microbiology laboratory and serves as a technical subject matter expert for microbiological testing, method qualification/validation, and aseptic manufacturing support. This role is responsible for independently executing microbiological studies and validations with minimal oversight and for providing strong scientific and hands‑on support to aseptic operations.

Responsibilities

• Independently perform and oversee microbiological testing of raw materials, in‑process samples, utilities, and finished drug products, including bioburden, sterility, endotoxins, microbial limits testing, growth promotion, BI enumeration, bacterial suspension preparation, sub‑visible particulates, AET, and CCIT.
• Execute, author, and manage microbiological method qualifications and validations in accordance with USP, compendial requirements, internal SOPs, and regulatory expectations.
• Serve as a technical SME for aseptic processing support, including environmental monitoring (viable and non‑viable), utilities monitoring (WFI, HPW, clean steam), and cleanroom behavior.
• Provide hands‑on support for aseptic operations, media fills, personnel monitoring, aseptic gowning qualification, and on‑the‑floor microbiology support as needed.
• Analyze, trend, and interpret environmental monitoring and microbiological data; identify adverse trends and support investigations, impact assessments, and CAPAs.
• Support and author microbiology‑related protocols, reports, deviations, investigations, and technical justifications.
• Participate in and support regulatory inspections, customer audits, and internal audits as a microbiology technical representative.
• Collaborate cross‑functionally with QA, Manufacturing, MSAT, Engineering, Facilities, Validation, and external partners to support new product introductions, process changes, and continuous improvement initiatives.
• Ensure all microbiology laboratory activities are performed in compliance with GMP/GDP requirements and that all equipment used is properly qualified, calibrated, and maintained.
• Maintain accurate, contemporaneous documentation in laboratory notebooks, controlled forms, and electronic systems (e.g., LIMS).
• Support training, mentoring, and technical development of junior microbiology staff.
• Maintain laboratory areas in a clean, organized, and inspection‑ready state; support laboratory operations activities as needed.
• Demonstrate a strong team‑oriented mindset with a willingness to roll up sleeves and execute laboratory and manufacturing‑support work as priorities require.
• Perform all other duties as assigned by the immediate supervisor.

Required Knowledge, Skills and Abilities

• Advanced hands‑on knowledge of pharmaceutical microbiological testing and aseptic processing principles.
• Ability to independently execute microbiological method qualifications and validations without direct supervision.
• Strong technical problem‑solving skills and ability to troubleshoot complex microbiological and aseptic issues.
• In‑depth understanding of GMP requirements and relevant USP chapters applicable to microbiology and sterile manufacturing.
• Excellent written and verbal communication skills.
• Proven ability to work effectively in a cross‑functional, fast‑paced manufacturing environment.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Proficient in standard computer applications (MS Word, Excel) and laboratory systems (e.g., LIMS); ability to quickly learn new systems.
• Knowledge of laboratory safety requirements and aseptic gowning practices.

Required Education and Experience

• Bachelor’s degree in Microbiology or a closely related scientific discipline (advanced degree preferred).
• Minimum of 8–10 years of experience in a pharmaceutical microbiology laboratory supporting sterile drug product manufacturing.
• Demonstrated experience executing microbiological method validation/qualification and providing direct aseptic operations support.
• GMP pharmaceutical experience required; experience supporting regulatory inspections strongly preferred.
• Candidates with a non‑Microbiology scientific degree and significant directly relevant microbiology experience will be considered.

Target Pay Range

$44–48 per hour + 2nd shift 10% differential.

Benefits

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability, Pet Insurance
• 401K