Role Summary
Reporting to the Plant Manager, the Project Engineer position is accountable for execution and support of high value, complex & strategic capital projects primarily in the Bimeda Sterile Manufacturing Site in Cambridge, Ontario
The Project Engineer will perform process engineering design to select appropriate equipment technology for a given process. Prepare detailed capital project request reports and execute project plans for various Engineering projects. Evaluate and control the execution process of the projects, conduct monitoring, acquire data, generate reports and communicate with all stakeholders and other support requirements for the manufacturing equipment and systems implementation.
Demonstrates an expert level of operational knowledge of sterile & non-sterile product manufacturing and/or other related and complimentary manufacturing processes to add value to investigations, evaluations and recommendations.
Demonstrates a thorough understanding of good manufacturing practices (GMP), good documentation practices (GDP), regulatory guidance requirements, safety and environmental controls. Accurately incorporates regulatory requirements governing proposed changes into written documents. Briefs stakeholders and senior management on the implications of regulatory requirements on projects and their timelines.
Key Role Specific Requirements
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