Microbiologist III - 2nd Shift

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.

Qualifications

• 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.