Consultant, Production Engineering

Responsible for project co-ordination activities within the Production Technical Department (i.e. site engineering support for production processes). This role consists of a range of responsibilities, from individual responsibility for overall project deliverables on existing process equipment upgrade projects and new equipment projects, through to supporting roles on major new development projects.

Acts as a resource with equipment/systems knowledge pertaining to a specific area of the compounding, filling/packaging or cleaning/sterilization equipment and processes installed at the site.

• Liaise with technical professionals and end-use customers to support the development of project scope and user requirements specifications that satisfy the business need.
• 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 supporting projects as assigned, aid in the delivery of project scope within budget and schedule.
• Prepare and/or co-ordinate the development of detailed drawings and specifications for assigned projects using AutoCAD and Apotex Standards.
• Participate in the selection, negotiation, management and evaluation of external suppliers and contractors.
• Liaise with end-use customers within Apotex to research, develop and analyse problems with existing facilities/equipment within their area of expertise 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/preventative action implementation for processes within their area of technical expertise.
• 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 as required by the current codes are obtained and that any necessary inspections and pre-start safety reviews are scheduled.
• Support the 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 Practises.
• 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.
• Support/lead the development and execution of F.A.T., S.A.T., commissioning and validation and change control requirements for work assigned.
• Assists Manager in meeting departmental goals and objectives.
• Performs additional related duties as assigned.
• Works as a member of a team to achieve all outcomes.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• 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.
• All other relevant duties as assigned.

• Education
  • A post-secondary degree in an Engineering/Technologist program (or equivalent field experience) accompanied by a minimum of two work terms of experience in plant technical support and/or design and construction co-ordination

• Knowledge, Skills and Abilities
  • Experience in project management is preferred.
  • Familiarity with Good Manufacturing Practices and the application of quality management systems is preferred.
  • Hands-on experience in design utilizing Autocad is preferred.
  • Hands on experience in the use of Microsoft Office, Excel and Visio.
  • Strong organizational and time management skills.
  • Ability to manage multiple priorities
  • Effective team player with good interpersonal and communication skills.
• Experience
  • Experience in pharmaceutical, food or other chemical processing industry, ideally with exposure to compounding, filling/packaging and cleaning/sterilization processes for liquid dose products is preferred.