Microbiologist III - 2nd Shift

Your Role

The Microbiologist III is a senior individual contributor within 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 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 but not limited to 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 through knowledge sharing, technical leadership, and hands-on guidance.
• Acts as a go-to technical resource for complex microbiology and aseptic processing questions.
• Maintain laboratory areas in a clean, organized, and inspection-ready state; support laboratory operations activities as needed (media prep, autoclave use, chart changes, inventory support).
• 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.
• Demonstrated 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, with the ability to clearly document and explain technical concepts.
• Proven ability to work effectively in a cross-functional, fast-paced manufacturing environment.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Hands-on, proactive, and collaborative team player with a strong work ethic.
• 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/hour + 2nd Shift 10% Differential

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.

Your Benefits

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