Microbiologist

Purpose Statement:

The Microbiology Technician will support the environmental monitoring and microbiological testing needs of a sterile pharmaceutical manufacturing facility and products. The role will be primarily responsible for environmental monitoring (EM), water and utility testing, microbiological testing of in-process and finished sterile IV bag products, and support of aseptic manufacturing qualification activities. This individual will play a critical role in maintaining the microbiology laboratory's compliance with regulatory standards and internal procedures, ensuring data integrity, and supporting the site’s sterility assurance program. The role will contribute to the successful startup, validation, and routine operation of the microbiology lab within a GMP-compliant environment supporting high potent APIs and controlled substances manufacturing.

Key Responsibilities:

1. Perform routine environmental monitoring in classified cleanroom areas.
2. Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.
3. Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.
4. Perform microbiological tests such as growth promotion, bioburden, endotoxin (LAL), and sterility for in-process, and finished products.
5. Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.
6. Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.
7. Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.
8. Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.
9. Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.
10. Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.

Qualifications / Experience:

• Associate’s or Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related field.
• 2-5 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Experience working in sterile environments or supporting aseptic processes preferred.
• Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.
• Knowledge of cGMPs, data integrity principles, and microbiological standards (USP <61> , <62> , <71> , <85> , <1116> , <788>).

Skills / Competencies:

• Strong attention to detail and commitment to data accuracy and integrity.
• Ability to work independently while collaborating effectively within a team.
• Good time management and organizational skills to support multiple tasks and priorities.
• Proficient in the use of Microsoft Office and basic laboratory software systems.
• Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.
• A proactive and patient-focused mindset with a strong sense of ownership and compliance.