Coordinator, Production Engineer

Apotex is a Canadian-based global health company with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices worldwide, we are the largest Canadian‑based pharmaceutical company and a health partner of choice for the Americas, providing licensing and product acquisitions.

Responsible for project co‑ordination activities within the Production Technical Department. This role includes overall deliverables on existing process equipment upgrade projects and new equipment projects, and supporting roles on major new development projects. The role provides guidance and acts as a resource with specialized knowledge of compounding, filling/packaging and cleaning/sterilization equipment and processes installed at the site.

• Liase with technical professionals and end‑use customers to lead and/or support the development of project scope and user requirement specifications that satisfy the business need.
• Lead and/or support the development of project design basis, justification documentation and Authorization for Expenditure.
• Prepare cost estimates, feasibility studies and execution schedules for assigned projects.
• In leading projects, ensure delivery of scope within budget and schedule.
• Prepare and/or coordinate detailed drawings and specifications using AutoCAD and Apotex Standards.
• Recommend external suppliers and contractors, managing selection, negotiation and evaluation.
• Research, develop and analyze problems with existing facilities/equipment and recommend improvement solutions.
• Collaborate with Launch, R&D and Operations to identify new product requirements and implement engineering solutions for new product readiness.
• Support Production, Maintenance and Complaints/Investigations groups with problem solving, troubleshooting, vendor liaison and project design.
• Develop SOPs, PM tasks, spare parts and calibration requirements with other departments.
• Coordinate outside consultants and contractors ensuring technical, regulatory, safety, cost and schedule compliance.
• Obtain necessary permits, certifications and schedule inspections and pre‑start safety reviews.
• Perform technical reviews of engineering specifications and test plans to meet user requirements and regulatory standards.
• Work with Start‑up Teams to ensure commissioning, qualification and training plans are in place for efficient system start‑up.
• Support development and execution of F.A.T., S.A.T., commissioning, validation and change control requirements.
• Lead Deviation Investigations, drive CAPA action and implement change control for continuous improvement.
• Support internal, customer and regulatory inspections as required.
• Assist Manager in meeting department goals and objectives.
• Work safely as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values:
  Collaboration, Courage, Perseverance and Passion.
• Maintain personal adherence to all compliance programs and policies.
• Perform all other relevant duties as assigned.

• Education
  • A post‑secondary degree in Engineering with a minimum of three to five years’ experience in plant technical support and/or design and construction coordination.
• Knowledge,
  
  Skills and Abilities
  • Experience in supporting Investigations/CAPA and Engineering Change Controls in Track Wise is preferred.
  • Experience in Project Management and use of MS Project is preferred.
  • Experience designing with AutoCAD is preferred.
  • Experience with 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 nasal products). Working knowledge of packaging components, automation systems, HVAC and utilities is preferred.

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

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