Microbiologist II

Microbiologist II (Direct Hire) —

Onsite Location:

Piscataway, NJ (onsite)

Travel:

South Plainfield, NJ (about 4 miles) — ~1x/week once trained / as needed

Schedule:

8:00 AM - 5:00 PM (some flexibility)

Start:

ASAP Salary Range:

$75,000 - $80,000 (base)

Department:

Microbiology Business Unit:

Quality Management Position Summary The Microbiologist II reports to Microbiology Management and works closely with management on department strategy and key projects. This role supports microbiological testing, product release, aseptic process quality, and data/document review in a regulated environment. Essential Duties & Responsibilities Coordinate microbiological testing, product release activities, and validation protocol testing Perform organism identification Perform technical review of batch filling records to ensure quality of aseptic processes Read and interpret microbiological cultures and related tests, including (but not limited to): Environmental monitoring Sterility testing Growth promotion Microbial limits testing Support validation, technology transfer, troubleshooting, and quality initiatives; may write policies/procedures Review and approve environmental monitoring data and lab equipment records Prepare process/status reports; assign/monitor document numbers; review documents for accuracy and completeness Perform other functions as required/assigned Comply with all company policies and standards Education / Experience BS or MS in a scientific discipline (or equivalent) with 2-4 years of related experience Expert knowledge of scientific principles and concepts Special Skills / Competencies Train other microbiologists on department methods, processes, and procedures Collaborate cross-functionally to accomplish company goals/projects Ability to read and interpret safety rules, operating/maintenance instructions, and procedure manuals Ability to write routine reports and correspondence Ability to speak effectively before groups/employees Ability to interpret instructions provided in written, oral, diagram, or schedule form Other special projects/duties as assigned by management Work Environment Lab and cleanroom settings (gowning required weekly) May include extended hours, weekends, or holidays during audits/deadlines Must be able to lift up to 25 lbs and work safely around chemicals and lab equipment Keywords / Skills Microbiology, Quality Control (QC), c

GMP, FDA

?regulated environment, Biologics, Biosimilars, Sterile drug products, Aseptic processing, Aseptic manufacturing, Fill?finish, Cleanroom operations, Gowning qualification, Environmental Monitoring (EM), Sterility testing, Growth promotion testing, Microbial limits testing, Bioburden testing, Endotoxin testing (LAL), Water testing (PW/WFI), Air and surface sampling, Media fills, Smoke studies, Microbial identification, Gram staining, MALDI?TOF, Culture interpretation, EM trending, Batch record review, Product release, Data integrity, GDP (Good Documentation Practices), SOP writing and review, Deviations, Investigations, CAPA, Method validation, Process validation, Technology transfer, Equipment qualification (IQ/OQ/PQ), Audit support, FDA inspections, Cross?functional collaboration, Training and mentoring. #M3- #

LI- Ref:

#558-Scientific