Microbiologist Ii

Description

The Microbiologist II, is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC., in Chicago, IL. This employee is responsible for supporting the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site's microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee's qualification in aseptic gown is required.

Essential Duties & Responsibilities

• Performs environmental monitoring of TPI-controlled and aseptic 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 compressed air (CA) and nitrogen gas (N2) 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

Education:

• A Bachelor's degree in microbiology, biology, or related discipline.

Experience:

• At least 3-5 years of experience in a cGMP pharmaceutical manufacturing environment is required. 
• Working knowledge of cGMP regulations (21 CFR 201/211/820) is required.

Special Skills:

• Good written and verbal communication skills.
• Use of air sampling EM equipment, such as AirIdeal, HACH Met Ones 3440 Series, Lasair III, and MiniCapt.
• Good organizational skills.
• Detail oriented.
• Must be able to effectively manage time to complete assignments.
• Familiarized with the use of Microsoft Excel and Microsoft Word. 

Work Environment & Physical Demands:

General Work Environment:

• General office setting and laboratory settings.
• Able to work wearing a full aseptic gowning at least 4 hours once weekly.
• Flexibility working weekend, holidays, or more than 8 hours a day, as required.
• Exposure to hazardous chemical, such as disinfectants, may occur, requiring personal protective equipment.
• Safety alertness is required due to work around hazardous equipment and conditions.

Noise:

• No extraordinary noise levels.

Standing/Lifting:

• Must be able to lift up to 25 lbs.

Visual:

• No special requirements.

Stress:

• High-paced demanding environment to meet ambition goals.

Travel: No travel required.

Supervisory Responsibility, if any: No

Benefits/Perks:

• Medical
• Dental
• Vision
• 401K
• FSA - Commuter/Transit
• Student Loan Assistance
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)
• On-site Gym
• Conveniently located next to the Metra, Green and Red Line
• One block east of the Chicago White Sox Stadium
• < 10 minutes away from Downtown Chicago

Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.