Engineering Technical Lead, Strategic Projects

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Responsible for project co‑ordination activities and acting as a Subject Matter Expert within the Strategic Projects Department. This role consists of a range of responsibilities, from individual accountability for overall project deliverables on strategic projects, processes and equipment through to supporting roles on delivery, installation and qualification of major new development projects. The Engineering Coordinator, Strategic Projects is responsible for providing guidance and acting as a resource with specialized knowledge pertaining to compounding, filling/packaging and cleaning/sterilization equipment and processes both sterile and non‑sterile which will be installed and operated at the Richmond Hill site.

• Liase with technical professionals and end use customers to lead and/or support the development of project scope and user requirements specifications that satisfy the business need.
• Lead and/or support the development of project design basis, project justification documentation and Authorization for Expenditure.
• Prepare cost estimates, feasibility studies and execution schedules for projects and/or portions thereof assigned.
• In leading projects as assigned, responsible for delivery of project scope within budget and schedule.
• Review and provide technical feedback on all design documentation (i.e. User requirement specifications, Function Specifications, Design Specifications).
• Provide recommendations to technical professionals/management relative to the selection, negotiation, management and evaluation of external suppliers and contractors.
• Liase with end use customers within Apotex to research, develop and analyse problems with existing facilities/equipment and recommend solutions for improvement or redevelopment.
• Liase with Launch, R&D and Operations to identify new product requirements and implement engineering solutions to ensure readiness to manufacture new products.
• Support the Production, Maintenance and Complaints/Investigations groups on an as‑needed basis with respect to problem solving, troubleshooting, vendor liaison, and development of project designs and corrective and preventative action implementation.
• Liase with other departments to develop SOPs, PM tasks, spare parts, and calibration requirements to support the equipment throughout its lifecycle.
• Co‑ordinate the activities of outside consultants and contractors in the execution of design and construction work, ensuring Apotex technical and regulatory compliance standards, safety, cost, and schedule parameters are maintained and reported.
• Ensure that all necessary permits and certifications are obtained and that any necessary inspections and pre‑start safety reviews are scheduled.
• Perform technical review of engineering specifications and test plans to ensure that all user requirements and business needs are met and adhere to regulatory standards and Good Engineering Practices.
• Use process systems expertise to work with individual Start‑up Teams, to ensure the appropriate commissioning, qualification and training plans with accompanying resources are in place to deliver efficient system start‑up.
• Lead and/or support the development and execution of F.A.T., S.A.T., commissioning, validation and change control requirements for work assigned.
• Supports internal, customer and regulatory inspections as required.
• Develop and maintain Alarm / Device criticality lists for equipment and processes.
• Manage Change control process for all equipment and processes associated with Strategic Projects.
• Assists Manager in meeting…