Microbiologist II

Kashiv BioSciences, LLC•Piscataway, NJ

About The Position

This individual works closely with Management on department strategy and work projects. Performs environmental monitoring of controlled manufacturing areas. Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles. Incubates viable samples. Streaks and sends representative EM isolates to contract laboratory for identification. Receives results and performs data entry for trend analysis. Complies with annual gowning qualification. Performs sanitation and temperature verification of laboratory refrigerators and incubators. Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems. Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity microbial count, and endotoxins. Performs routine monitoring of gases for viable particles, non-viable particles, oil, and moisture. Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples. Performs gram stain and growth promotion tests. Performs tests for bioburden and microbial limit. Performs visual inspection of microbiological, EM samples and media fill units. Performs data entry of results in Excel for trend analysis. Reviews microbiology laboratory data. Generates OOS or Out of EM Action/Alert Levels Notification, when required. Lead laboratory investigations and/or support manufacturing investigations, when required. Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes. Lead procedures, methods or specifications revisions acting as Contributor using Master Control System. Other tasks as requested by management.

Requirements

BS or MS in a scientific discipline or equivalent and a minimum 2-4 years related experience.
Expert knowledge of scientific principles and concepts.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and/or correspondence.
Ability to speak effectively before groups or employees of organization.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Nice To Haves

Other special projects and/or duties may be assigned by Management.
Trains other Microbiologist on Department methods, process and procedure.
Works with other departments to accomplish Company goals or projects.

Responsibilities

Performs environmental monitoring of controlled manufacturing areas.
Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
Incubates viable samples.
Streaks and sends representative EM isolates to contract laboratory for identification.
Receives results and performs data entry for trend analysis.
Complies with annual gowning qualification.
Performs sanitation and temperature verification of laboratory refrigerators and incubators.
Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems.
Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity microbial count, and endotoxins.
Performs routine monitoring of gases for viable particles, non-viable particles, oil, and moisture.
Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
Performs gram stain and growth promotion tests.
Performs tests for bioburden and microbial limit.
Performs visual inspection of microbiological, EM samples and media fill units.
Performs data entry of results in Excel for trend analysis.
Reviews microbiology laboratory data.
Generates OOS or Out of EM Action/Alert Levels Notification, when required.
Lead laboratory investigations and/or support manufacturing investigations, when required.
Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes.
Lead procedures, methods or specifications revisions acting as Contributor using Master Control System.
Other tasks as requested by management.