Responsibilities:

1. Perform microbiological testing including bioburden, endotoxin (kinetic turbidimetric & gel clot), particulate matter, and 14-day sterility testing in accordance with USP and internal SOPs.
2. Conduct environmental monitoring in classified cleanroom environments (viable/non-viable air sampling, surface sampling, personnel monitoring).
3. Perform facility water system and clean steam sampling, including microbial and endotoxin testing.
4. Enter, review, and trend laboratory data within LIMS; identify atypical results and escalate as needed.
5. Conduct OOS, OOT, and deviation investigations; support root cause analysis and documentation.
6. Assist with CAPA implementation and continuous improvement initiatives.
7. Support cleaning validation, process validation, and special microbiological studies.
8. Maintain laboratory equipment including autoclaves, glassware washers, particle counters, and isolator systems.
9. Participate in internal audits and regulatory inspections as required.
10. Train and mentor junior analysts on microbiological techniques and GMP compliance.

Requirements:

1. Bachelor’s degree in Microbiology, Biology, or related life science.
2. 4+ years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotech environment.
3. Hands-on experience with environmental monitoring in cleanrooms (ISO classified environments preferred).
4. Experience with LAL testing (kinetic & gel clot), sterility testing, filtration methods, and particulate matter testing.
5. Strong working knowledge of cGMPs, USP standards, FDA regulations, and GLPs.
6. Experience conducting investigations (OOS/OOT), writing reports, and supporting CAPAs.
7. Proficiency with LIMS systems and Microsoft Office (Excel, PowerPoint, etc.).
8. Strong written and verbal communication skills with ability to collaborate cross-functionally.