Microbiologist II
About The Position
The Microbiologist II supports the Microbiology and Environmental Monitoring (EM) department in implementing and managing site microbiology and EM programs and laboratory operations to ensure compliance with current regulations. The role interacts directly with manufacturing processes for biological non-sterile drug substance and sterile drug product, and requires qualification in aseptic gowning. The position performs environmental and utility monitoring, microbiological testing, data entry and review, trend analysis, and laboratory investigations. It also supports manufacturing investigations and prepares change controls and controlled-document revisions as needed. The work takes place in general office and laboratory settings. The employee must be able to wear full aseptic gowning for at least four hours once weekly, and may work weekends, holidays, or more than eight hours a day as required. The role may involve exposure to hazardous chemicals such as disinfectants and work around hazardous equipment and conditions, requiring personal protective equipment and safety alertness. The employee must be able to lift up to 25 pounds.
Requirements
- Bachelor’s degree in microbiology, biology, or a related discipline.
- At least 3–5 years of experience in a cGMP pharmaceutical manufacturing environment.
- Working knowledge of cGMP regulations (21 CFR 201/211/820).
- Good written and verbal communication skills.
- Experience using air-sampling environmental monitoring equipment, such as AirIdeal, HACH Met Ones 3440 Series, Lasair III, and MiniCapt.
- Good organizational skills.
- Attention to detail.
- Ability to manage time effectively to complete assignments.
- Familiarity with Microsoft Excel and Microsoft Word.
- Qualification in aseptic gowning.
- Ability to wear full aseptic gowning for at least four hours once weekly.
- Ability to lift up to 25 pounds.
Responsibilities
- Perform environmental monitoring of TPI-controlled and aseptic manufacturing areas.
- Collect samples for viable surface, gowning, and air monitoring and non-viable air particle monitoring.
- Incubate viable samples.
- Streak and send representative environmental monitoring isolates to a contract laboratory for identification; receive results and enter data for trend analysis.
- Maintain annual gowning qualification.
- Perform sanitation and temperature verification of laboratory refrigerators and incubators.
- Perform routine monitoring of water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
- Submit samples for testing by the microbiology laboratory or a contracted laboratory for TOC, conductivity, microbial count, and endotoxins.
- Perform routine monitoring of compressed air and nitrogen gas for viable and non-viable particles, oil, and moisture.
- Perform bacterial endotoxin testing of WFI, CS, in-process control, intermediate product, drug substance, and drug product samples.
- Perform Gram stain and growth promotion tests.
- Perform bioburden and microbial limit tests.
- Visually inspect microbiological and environmental monitoring samples and media fill units.
- Enter results in Excel for trend analysis.
- Review microbiology laboratory data.
- Generate out-of-specification or out-of-environmental-monitoring action/alert-level notifications when required.
- Lead laboratory investigations and/or support manufacturing investigations when required.
- Generate change controls for equipment or instrument qualifications, process changes, or document changes.
- Lead procedure, method, or specification revisions as a contributor using the Master Control System.
- Complete other tasks as requested by management.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
- Long-term incentive award, such as restricted stock units, within the first 12 months.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
