The Microbiologist II is a key member of the Microbiology and Environmental Monitoring (EM) team, supporting microbiology and EM programs, and ensuring compliance with regulatory standards. This role involves direct interaction with biological non-sterile drug substances and sterile drug product manufacturing processes. Aseptic gowning qualification is required.

Essential Duties & Responsibilities:

• Conduct environmental monitoring in TPI-controlled and aseptic manufacturing areas.
• Collect viable (surface, gowning, air) and non-viable (air) particle samples.
• Incubate viable samples and manage EM isolates, including data entry for trend analysis.
• Ensure compliance with annual gowning qualifications.
• Perform routine sanitation, temperature verification for lab refrigerators, and incubators.
• Monitor water systems (WFI, RO, PW, CS) and submit samples for testing (TOC, conductivity, microbial count, endotoxins).
• Conduct tests for compressed air (CA) and nitrogen gas (N2) for viable and non-viable particles, oil, and moisture.
• Execute bacterial endotoxin tests for WFI, CS, IPC, IP, DS, and DP samples.
• Perform gram staining, growth promotion, bioburden, and microbial limit tests.
• Visually inspect microbiological, EM samples, and media fill units.
• Enter data into Excel for trend analysis and review laboratory data.
• Generate notifications for Out of Specification (OOS) or EM Action/Alert Level deviations, as needed.
• Lead or support laboratory and manufacturing investigations.
• Initiate change controls for equipment/instrument qualifications, processes, or document updates.
• Act as a Contributor for procedure, method, or specification revisions in the Master Control System.
• Undertake additional tasks as requested by management.

Requirements:

Education:

• Bachelor’s degree in microbiology, biology, or related field.

Experience:

• Minimum 3-5 years in a cGMP pharmaceutical manufacturing environment.
• Knowledge of cGMP regulations (21 CFR 201/211/820).

Special Skills:

• Strong written and verbal communication.
• Proficiency with EM equipment (AirIdeal, HACH Met Ones 3440 Series, Lasair III, MiniCapt).
• Organizational and detail-oriented skills.
• Time management skills to meet deadlines.
• Familiarity with Microsoft Excel and Word.

Work Environment & Physical Demands:

• General Environment: Office and laboratory settings.
• Aseptic Gowning: Able to work in full aseptic gowning for at least 4 hours weekly.
• Flexible Hours: Availability to work weekends, holidays, or over 8 hours per day, as required.
• Exposure: Possible exposure to hazardous chemicals (e.g., disinfectants); requires use of personal protective equipment.
• Safety Alertness: Required around hazardous equipment and conditions.