Project Engineer

at  Omniabio

EXPERIENCE

• Bachelor’s degree or higher in Biochemical, Mechanical, or Industrial Engineering or other similar Engineering field.
• Professional Engineer, licensed with the Professional Engineers of Ontario.
• Minimum 8 years direct experience designing, installing and/or maintaining industrial systems.
• Previous experience in a pharmaceutical or biopharmaceutical industry.
• Good understanding of cGMP and sterile equipment and facility design requirements.
• Expertise in GMP cleanroom Facilities and their associated equipment
• Experience with engineering systems in a GMP environment, including, but not limited to, maintenance work orders, calibration, lifecycle management, validation and change control.
• General knowledge of process development and quality control lab equipment.
• Experience with new facility start-up is a plus.
• Minimum of 5 years with Autocad or similar and drawing document management.

ROLE SUMMARY:

This position is responsible for the implementation of client processes into GMP as well as supportive services in the OmniaBio Hamilton facility. The Project Engineer will provide in-house engineering expertise, ensuring that process and equipment, including supporting materials and systems and are designed, installed and operate in compliance with the client requirements and appropriate quality and safety regulations.

RESPONSIBILITIES:

• Develop project design concepts, justification, scope, specifications, and cost estimates. Create and manage detailed project timelines and schedules.
• Responsible for URS process including drafting, Approval and final reconciliation of purchased equipment and ensuring technical teams needs are met.
• Liaise with all levels across the organization to lead activities and communicate project status and impacts.
• Liaise with Clients for set up and requirements of equipment based on customer requirements as part of the technology transfer process.
• Manage contractors and consultants related to design and development both in implementation and change.
• Use SAP and other data to evaluate existing systems for operational effectiveness, safety, quality, and business risk. Develop plans to mitigate risk and improve compliance and reliability.
• Oversee operation and function of the liquid waste management system.
• Responsible for equipment, facility, utilities and supporting systems design and installation in support of new project/product introduction within the GMP manufacturing area.
• Support daily manufacturing operations and ensure process and facility equipment systems remain operational by providing engineering support for GMP process equipment and support.
• Troubleshoot complex facility and process equipment problems and provide optimization strategies and improvements for assigned systems.
• Work with the Facilities team providing input to preventative maintenance plans, spare part inventory and support of CMMS build and maintenance.
• Serve as an Engineering subject matter expert (SME) to lead deviation investigations, root cause analysis, and CAPA identification.
• Develop and execute engineering tests, FATs, SATs and commissioning test plans.
• Support validation activities (IQ/OQ/PQ) and exceptions encountered during execution.
• Create and revise engineering, P&ID, PFD and related drawings. Act as mentor and advisor to project engineers, co-op students and facility supervisors.
• Support MSAT and Manufacturing in set up and optimization of new cleanroom equipment layouts ensuring client needs are met with minimal facility changes
• Inform Site leadership team of CAPEX changes required to the facility and lead in the design and execution of the change
• Participate in Safety evaluations (HAZOP, Changes controls etc)
• Leverage cutting edge and effective solutions to drive continuous improvement in connection to OmniaBio’s Operating Model “OBOM”