As a Junior CQ Engineer, the candidate would be responsible for supporting the implementation of commissioning and qualification activities for the fit-
out equipment of a new bulk vaccine manufacturing facility. This position is based in Toronto, Ontario (Canada). Main Accountabilities Support the Senior and Intermediate CQ Engineers by performing andor executing the following scope of work, at a minimum System boundary reviews Traceability Matrix Generation Support System SOP Generation Project Change Control Issuance and Review Front-
end documentation review Commissioning plan creationexecution SAT vendor documentation review Design review support Commissioning protocol generationexecution Facility and equipment start-
up support IVOV commissioning test protocol generationexecutionreport generation Cycle development test protocol generationexecutionreport generation PQ test protocol generationexecutionreport generation Site training.
Implement company and industry (i.e. ASTM-e2500) guidelines to ensure project quality delivery. Continually align on project expectations with the Senior and Intermediate CQ Engineers.
Identify potential risks during commissioning and qualification activities. Track assigned deliverables and activities using appropriate tools to provide that information to the Senior and Intermediate CQ Engineers, as required.
Ideal Profile 2+ years of commissioning qualification experience working in biopharmaceutical manufacturing environments.
Demonstrable work experience applying the ASTM-e2500 guidelines is preferred. Familiarity with applicable Canada, US and worldwide regulatory requirements.
Understanding of Validation using risk based approach (FMEA) is preferred. A bachelorrsquos degree in Engineering or Science.
A degree in Mechanical or Electrical Engineering is preferred. Excellent technical and communication skills. Excellent reading and writing skills in the English language.