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Job Summary:

The Microbiologist I performs routine and non-routine microbiological testing, environmental

monitoring, and data review to ensure aseptic control of classified areas. This role supports ongoing

contamination control efforts, batch disposition, and investigation activities.

Responsibilities:

• Conduct viable, non-viable, and surface environmental monitoring across classified areas (ISO 5–

8).

• Enumerate and verify environmental samples, media fills, and gowning plates.

• Perform morphological assessments and basic microbial identifications.

• Document test results and deviations accurately in laboratory records.

• Maintain calibration and preventive maintenance of environmental monitoring equipment.

• Participate in routine cleaning, disinfectant rotation, and lab upkeep.

• Support trending and data review of EM and utility monitoring programs.

• Conduct investigations and support maintenance of the Environmental monitoring program.

• Write out-of-specification investigations and assist with CAPA execution.

• Follow all gowning, aseptic, and cGMP requirements for Grade A/B/C/D spaces.

• Solve process, procedural, equipment issues via experimentation or revision of procedures.

• Develop necessary submission documentation, for the FDA and/or other regulatory bodies.

• Perform other duties as assigned by management.

Required Skills/Abilities: (examples)

• Excellent verbal and written communication skills.

• Excellent interpersonal and customer service skills.

• Preferred previous pharmaceutical experience, 503b compounding facility experience desired..

• Familiarity with 21 CFR Part 11/210/211

• Working knowledge of aseptic technique and microbiological testing.

• Understanding of cleanroom behavior and contamination control principles.

• Strong organization, documentation, and time management skills.

• Ability to interpret environmental monitoring data.

• Familiarity with USP <71>, <85>, <1116>, <1117>, and Annex 1 preferred.

Education and Experience:

• B.S. or B.A. in Microbiology or a closely related field / or equivalent experience

• Experience with cGMP aseptic manufacturing environment.

• Minimum one year experience in a sterile, cGMP, and quality control

environment.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.

• Must be able to lift up to 15 pounds at times.