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Senior Project Engineer
1 month ago
Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations. Our focus on vertical integration enables us to develop and sell generic, biosimilar, and specialty products.
For more information, visit www.apotex.com.
Job SummaryThe Senior Project Engineer is responsible for the development and implementation of capital projects across the site. This includes selecting equipment, preparing requests for proposal, and developing validation master plans. As an integral part of the engineering team, the incumbent provides mentorship and guidance to maintenance supervisors and other engineers.
Key Responsibilities- Act as a mentor and advisor to project engineers and maintenance supervisors.
- Provide project management for assigned projects and assignments.
- Perform complete engineering design to select appropriate equipment technology for a given process.
- Evaluate various economic options, develop project schedules, and prepare overall project impact summaries, including cost-benefit analyses.
- Prepare detailed capital project requests, equipment procurement specifications, and vendor contracts as per overall guidelines.
- Perform technical analysis of each utility where required.
- Evaluate process control, monitoring, data acquisition, and other support requirements for manufacturing.
- Provide production support for technical parameters such as heat and mass transfer, mixing characteristics, using available equipment to meet these parameters.
- Coordinate with vendors for inspection and testing of new equipment, supervise installation, and commission.
- Conduct HAZOP studies with R&D and the Process group and provide necessary facility design features to ensure safety throughout all plants.
- Provide technical support for deviation investigations, lead deviations as required.
- Prepare and route change control documents as required to support the Qualifications group.
- Provide all necessary inputs to the Qualifications Group for IQ/OQ/PQ of new equipment and facility.
- Meet all deadlines associated with projects as directed, including all reports and documentation as directed.
- Keep the Management up-to-date on project schedules.
- Ensure continuous professional development by regular literature review.
- Conform to the principles of cGMP and conform with all relevant departmental and other company standard operating procedures.
- Ensure support and guidance are given to departmental employees, and ensure professional skill development.
- Work in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate behaviors 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.
- Education: Bachelor's degree or higher in Chemical, Mechanical, or Industrial Engineering.
- Professional Engineer, licensed with the Professional Engineers of Ontario.
- Knowledge, Skills, and Abilities:
- Familiar with GMP, FDA, HPB, ISO requirements, and Validation concepts and protocols.
- Good working knowledge of distributed control systems, specifically DeltaV.
- Experience:
- Minimum of five years working in the pharmaceutical industry.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected, and supported.
Apotex offers 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.