QC Microbiologist- Princeton, New Jersey- Full Benefits, 401K and PTO
Essential Functions of the Job:
- Perform utilities sampling for Water for Injection (WFI), Purified Water (PW), Clean Steam, and Process gases.
- Conduct environmental monitoring of cleanroom suites and laboratory areas as required.
- Perform QC Microbiology laboratory testing, including bioburden, endotoxin, sterility, and microbial identification testing, to ensure timely generation and reporting of test results for in-process, drug substance, drug product, and stability samples in support of manufacturing operations.
- Support routine QC operations, including instrument qualification and maintenance, SOP generation and revision, specification updates, record-keeping, and archival.
- Conduct laboratory investigations, including Out of Specification (OOS), Out of Trend (OOT), deviations, and invalid assays.
- Implement Corrective Actions and Preventive Actions (CAPAs).
- Participate in facility qualification activities for microbiological testing and environmental monitoring.
- Required to gown into cleanrooms with different classifications and stand/move around for extended periods.
- Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
Core Competencies, Knowledge, and Skill Requirements:
- Bachelor's Degree or higher in Microbiology, Biology, Biotechnology, or a related scientific discipline. Minimum of 2 years of experience in an FDA-regulated biotechnology or pharmaceutical company.
- 5+ years of experience preferred for candidates without higher education.
- Strong working knowledge and hands-on experience with microbiological testing methods such as endotoxin testing, bioburden, sterility testing, microbial identification, PCR, biological indicators, and environmental monitoring.
- Familiarity with USP/EP and cGMP/EU GMP regulations.
- Experience with instrument and equipment validation.