Microbiologist
$70,000–$80,000 year
On-siteMississauga, Ontario, Canada
Job Summary
Conduct environmental monitoring of cleanroom facilities and personnel, including microbial analysis, temperature, humidity, and particulate checks. Prepare trend analysis reports and present findings to senior leadership. Plan and oversee facility qualification activities such as EMPQ and media fills. Perform microbial enumeration, isolation, and identification of bacteria, yeast, and mold from purified water, raw materials, and environmental samples. Investigate out-of-specification test results, document root causes, and implement corrective actions. Author, review, and update standard operating procedures and protocols to ensure compliance with GMP and ISO 13485 standards. Train manufacturing staff on aseptic practices and contamination control principles. Lead the design and qualification of an in-house microbiology lab to transition testing from external to internal control. Report to the Vice-President, Manufacturing and Service, with a 37.5-hour week in Mississauga.
Required Qualifications
- University degree in microbiology, or related science discipline with evidence of completion of microbiology courses
- 3 years of practical working experience of working as a Microbiologist in commercial, laboratory, or research setting
- Working knowledge of the methods, materials, and aseptic techniques used in laboratory work
- Working knowledge of the use of laboratory apparatus and equipment
- Ability to communicate clearly and concisely both orally and in writing
- Competency in clearly and fluently expressing concepts and ideas in English, orally and in writing
- Ability to work as a member of a team and under minimum supervision
- Ability to prepare, interpret and generate routine test reports in a timely manner and in accordance with internal and regulatory guidelines to meet timelines
- Flexibility to work in a fast-paced environment and willing to take initiative to develop and improve processes
- Must be able to lift 50 lbs
Desired Qualifications
- Experience working under a quality management system (pharmaceutical or medical device) is an asset
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