Job Summary
The Senior Project Engineer is responsible for the development and implementation of capital projects throughout the site, including the selection of equipment, preparing requests for proposal and developing the validation master plan. An integral part of the engineering team, the incumbent also provides mentorship and guidance to maintenance supervisors and other engineers.
Job Responsibilities
Act as mentor and advisor to the project engineers and the maintenance supervisors.
Provide project management for all assigned projects and assignments.
Perform complete engineering design to select appropriate equipment technology for a given process.
Evaluate various economic options, develop project schedule and prepare overall project impact summary, including cost benefit analysis.
Prepare detailed capital project requests, equipment procurement specifications and vendor’s contracts asper overall guidelines.
Perform technical analysis of each utility where required.
Evaluate process control, monitoring, data acquisition and other support requirements for the manufacturing.
Provide production support for technical parameters such as heat and mass transfer, mixing characteristics, using available equipment to meet these parameters.
Coordinate with vendor 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.
To meet all deadlines associated with projects as directed, including all reports and documentation as directed.
To keep the Management up-to-date on project schedules.
To ensure continuous professional development by regular literature review.
To conform to the principles of cGMP and to conform with all relevant departmental and other company standard operating procedures.
To ensure support and guidance is given to departmental employees, and ensure professional skill development.
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.
Job Requirements
Education
Bachelor’s degree or higher in Chemical, Mechanical, or Industrial Engineering.
Professional Engineer, licensed with the Professional Engineers of Ontario preferred.
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 a GMP manufacturer industry.
If interested, please contact Phil DuBois at pdubois@prideinpersonnel.com