KB Microbiologist I
About The Position
The Microbiologist I supports the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site’s microbiology and EM programs and overall microbiology laboratory operations to ensure compliance with current regulations. The role directly interacts with manufacturing processes for biological non-sterile drug substance and sterile drug product, and requires qualification in aseptic gowning. The position includes monitoring manufacturing and utility systems, collecting and processing microbiological samples, performing laboratory testing, and entering results for trend analysis. The work takes place in general office and laboratory settings and may involve wearing full aseptic gowning, exposure to hazardous chemicals, and working around hazardous equipment and conditions.
Requirements
- Bachelor’s degree in microbiology, biology, or a related discipline.
- Good written and verbal communication skills.
- 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 is required.
- Ability to work wearing full aseptic gowning for at least four hours once weekly.
- Ability to lift up to 25 lbs.
Nice To Haves
- 0–2 years of experience in a cGMP pharmaceutical manufacturing environment is preferred.
Responsibilities
- Perform environmental monitoring of Kashiv-controlled and aseptic manufacturing areas.
- Collect samples to detect viable surface, gowning, and air particles, as well as non-viable air particles.
- Incubate viable samples.
- Streak and send representative EM 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 to the microbiology laboratory or a contracted laboratory for total organic carbon (TOC), conductivity, microbial count, and endotoxin testing.
- Perform routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, and moisture.
- Perform bacterial endotoxin testing on WFI, CS, in-process control (IPC), intermediate product (IP), drug substance (DS), and drug product (DP) samples.
- Perform gram stain and growth promotion tests.
- Perform bioburden and microbial limit tests.
- Visually inspect microbiological and EM samples and media fill units.
- Enter results in Excel for trend analysis.
- Perform 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.
- Comprehensive, flexible benefits program for eligible positions.
- 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
Entry Level
