Process/Project Engineer

1 month ago

Toronto, Canada Fortis Life Sciences Full time

International Point of Care is an Etobicoke, ON-based company specialized in the area of rapid point-of-care. We develop, manufacture, and supply unique biological reagents, raw materials, and lateral flow components for the in-vitro diagnostic industry and the research and development community.


Position Summary:


• Support and or execute validation programs, verification activities and technology transfer requirements for new or improved manufacturing equipment.
• Develop and deliver equipment and system operating progress reports, proposals, requirements documentation.
• Train and become proficient on equipment used for the processes and activities required to produce rapid lateral flow immunoassay tests (beaded reagents, antibody production and purification, reagent conjugations and striping, etc.).
• Provide engineering support and expertise for process improvements, where applicable.
• Devising automation for making products at the required scale and/or evaluating existing equipment and processes to identify areas for improvement.
• Optimize manufacturing equipment by refining existing processes or devising new processes.
• Implementing equipment process controls and devising test methods to assess production equipment.
• Effectively communicate project expectations to team members and stakeholders
in a timely and clear fashion.
• Estimate the resources and participants needed to achieve project goals.
• Interact and coordinate with contractors, suppliers and equipment manufacturers, in the management of project activities.
• When requested, participate in Quality investigations and procedures (NCRs, CAPAs, etc.) with Engineering support of development and manufacturing.
• Interact and coordinate with Senior Management and Department Heads in the management of Equipment project activities (Facility/equipment use, etc.).
• Attend regular status meetings with project teams.
• Assist in the development and preparation of Validation Plans, Equipment Qualification Plans (IQ/OQ/PQ), and Risk Management documents as well as standard operating procedures (SOPs), with adherence to regulatory guidelines.
• Ensure that all engineering work is performed in full compliance with, established safety standards and regulatory requirements.

Education and Experience:


• University Degree or College equivalent in a scientific discipline (Engineering)
• 3-5years direct work experience in a manufacturing company in the capacity of Engineering, preferably with a regulated medical device company and a track record of solving engineering problems in a hands on, creative and team orientated environment.

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