Microbiologist

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.