Microbiologist I - Sterile

About the role

The Microbiologist I operates independently in a cleanroom laboratory setting to perform routine microbiological testing, environmental monitoring, and sample handling in compliance with regulatory standards. This role ensures accurate and timely testing while maintaining strict adherence to cGMP, cGLP, and company SOPs. The position also supports continuous improvement initiatives, proper documentation, and cross-functional collaboration.

Responsibilities

• Operate independently while maintaining a high level of responsibility for assigned tasks, conducting routine testing on samples—including sterility and endotoxin testing—in a timely manner to ensure compliance with regulatory standards.
• Perform routine environmental monitoring of clean rooms, including the reading and interpretation of environmental monitoring (EM) plates.
• Check method suitability for sterility tests and assist in troubleshooting any issues related to laboratory procedures.
• Maintain the proper chain of custody for all samples, effectively managing aliquoting, storage, receipt, and shipping processes.
• Participate in clean lab operations, preventive actions, and continuous improvement programs to reduce operating costs and enhance efficiency.
• Enter and verify data in compliance with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP), ensuring data integrity and accuracy.
• Maintain various logbooks and documentation in accordance with Standard Operating Procedures (SOPs).
• Support the training and onboarding of new team members to ensure their competency and compliance with laboratory procedures.
• Communicate effectively across departments—including Quality Assurance, Client Care, and other internal teams—to ensure smooth workflow and alignment with company objectives.

Requirements

• Bachelor’s degree in Biology, Microbiology, or a related field, or equivalent relevant experience.
• Preferred experience in sterility testing and cleanroom operations; experience in cGLP and/or cGMP regulated laboratory environments is a plus.
• Strong understanding of microbiological principles, techniques, and laboratory protocols, with the ability to clearly communicate technical information.
• Proficiency in laboratory data entry and laboratory information or data management systems.
• Excellent attention to detail, strong organizational skills, and the ability to maintain accurate documentation in compliance with company policies, SOPs, and safety regulations.
• Ability to manage time effectively, maintain focus, meet established timelines, and adapt to new processes and skills as required.
• Ability to work independently with minimal supervision as well as collaboratively in a team environment, following instructions accurately and communicating effectively across disciplines.
• Ability to execute tasks in a cleanroom environment; head-to-toe PPE (including full bunny suit) is required at all times.
• Ability to stand for extended periods while conducting testing procedures, with the physical dexterity to perform testing accurately and precisely.
• Frequent use of laboratory equipment and routine exposure to chemicals in a controlled, regulated setting.

Skills Preferred

• Critical Thinking
• Troubleshooting
• Detail Oriented
• Time Management

Behaviors Preferred

• Dedicated
• Team Player

Education Preferred

• Bachelor’s or better in Biology or related field.
• Bachelor’s or better in Microbiology or related field.

Experience

• Licenses & Certifications: Not specified.

Qualifications

• Not specified.

Skills

• Not specified.

Benefits

Not specified.

Pay

Not specified.

Schedule

Not specified.