Facility Engineer

About OmniaBio:

OmniaBio Inc.
is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to
transform biomanufacturing with AI and automation.
Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting-edge therapies worldwide.

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Position 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"

Qualifications:

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.

Behaviours

• Critical thinker.
• Excellent analytical and problem-solving skills.
• Ability to articulate technical understanding to non-technical SMEs.
• Compliance mind-set.
• Ability to respond to urgent situations.
• Tenacious.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant's compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.