Job Description

ALTEN Canada is hiring a Microbiologist in Alliston, ON.

Location: Alliston, ON

Work Model: Onsite

Shift: Rotating

Weekends required: Yes

Scope of the role:

As a Microbiologist, you hold a B.Sc. designation. You will perform daily solution bio burden, particulate matter and perform pyrogen testing. You will collect and process viable and non-viable air, water, solution, and surface samples as part of the Environmental monitoring program. You will potentially conduct biological indicator work for sterilizer qualifications and provide backup to other areas of the Sterility Assurance Department when needed.

Microbiologist Responsibilities:

• 10% Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program. Conduct the required testing and incubation of these samples in accordance with specifications
• 50% Perform daily solution bio burden testing, examining total count, coliform count and spore count in accordance with SOP
• Ensure required documentation is completed, and required samples are accounted for
• Conduct testing of raw materials upon request
• 10% Collect and organize production samples and check for discrepancies against sterilized sample record
• Maintain equipment and area for testing to ensure endotoxin free product and perform bacterial endotoxin testing per specification
• 10% Perform required testing and complete documentation required for critical work request and protocols by prioritizing daily and weekly testing schedules to allow time for required tests
• 5% Maintain 6S within the lab areas assigned. Provide back-up coverage to the Sterility Assurance Department when needed
• 10% Prepare, growth test and pH adjust a variety of media and buffer solutions, required for Sterility testing and Environmental monitoring. Rehydrate organisms and maintain stock cultures used for growth testing
• 5% Maintain equipment inventories and order laboratory supplies as needed. Ensure equipment calibrations are performed in a timely manner. Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and perform monthly preventive maintenance. Monitor incubator and refrigerator charts and thermometers daily

• University Degree, B.Sc. designation
• Experience in manufacturing environments, quality assurance and microbiology
• Knowledge of Aseptic Technique and Microbiological Methods
• Previous experience with Laboratory Information Management System (LIMS)
• Microbiological testing lab experience in the pharmaceutical industry
• Knowledge of GMP, ISO standards and regulatory/corporate requirements
• Ability to work off shift, holidays and plant shut-downs on a rotating basis
• Coverage for production overtime on Saturdays on a rotating basis is mandatory
• Must comply with Good Laboratory Practices
• Will be performing Sterilizer Quals: Note - the work is conducted in extreme environmental conditions (temperature, humidity, wet, moving trucks, loud, hot pipes)
• Understanding of EMS through the application of LEAN tools in a laboratory environment
• MS office skills required to produce technical writing documents

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