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 performance and reliability of facility and process equipment in the OmniaBio Hamilton facility. The Facility Engineer will provide in-house engineering expertise, ensuring that process and facility equipment systems are designed, installed and maintained in compliance with the appropriate quality and safety regulations.

RESPONSIBILITIES:

• Develop project design concepts, justification, scope, specifications, and cost estimates. Create and manage detailed project timelines and schedules.
• 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”