Microbiologist II

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

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.

• 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

• BS or MS in a scientific discipline (or equivalent) with 2–4 years of related experience
• Expert knowledge of scientific principles and concepts

• 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

• 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

Microbiology, Quality Control (QC), cGMP, 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.