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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Job Summary

Responsible for project co-ordination activities and acting as a Subject Mater 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.

Job Responsibilities

• 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 department goals and objectives.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

• Uses expertise in aseptic processing to ensure alignment with cGMP, sterility assurance standards, and regulatory expectations.

• Leverages knowledge of aseptic processing to evaluate workflows, identify risks, and implement controls that maintain sterile conditions.

• All other relevant duties as assigned.

Job Requirements

• Education A post-secondary degree in Engineering accompanied by a minimum of three to five years’ experience in plant technical support and/or design and construction co-ordination.
• Knowledge, Skills and Abilities Experience in supporting Investigations/CAPA and Engineering Change Controls in TrackWise is preferred. Experience in Project Management and use of MS Project is preferred. Experience in design utilizing Autocad is preferred. Experience in the use of Microsoft Office, Excel, Visio, and SAP is required. Strong organizational and time management skills. Good interpersonal and communication skills. Certified packaging professional, PMP or P.Eng. designation is an asset.
• Experience Experience in the pharmaceutical, food, or other chemical processing industry, ideally with exposure to compounding, filling/packaging, and cleaning/sterilization processes for liquid dose products (sterile ophthalmic and nasals products). Working knowledge of pharmaceutical packaging components, automation systems, HVAC and utilities preferred.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.