Process Engineering Specialist II
OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.
Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.comto learn more.
This role is responsible for the performance and reliability of process equipment in the OmniaBio facility. The Process Engineering Specialist II will provide in-house engineering expertise ensuring that process equipment systems are designed, installed, and maintained in compliance with the appropriate quality and safety regulations.
- Responsible for equipment system design and installation in support of new project/product introduction within the GMP manufacturing area.
- Support daily manufacturing operations and ensure process equipment systems remain operational by providing engineering support for GMP process equipment and support.
- Identify areas of risk and improvement regarding operational effectiveness, safety, quality, and reliability.
- Troubleshoot complex process equipment problems and provide optimization strategies and improvements for assigned systems.
- Lead root cause analysis for equipment failures and collaborate with cross-functional stakeholders to determine the best path forward to identified issues by balancing technical, compliance, and business objectives.
- Work with Facilities team providing input to preventative maintenance plans, spare part inventory and support of CMMS build and maintenance.
- Serves as Subject Matter Expert (SME) in support of deviation investigations, root cause analysis, and CAPA identification and implementation for process equipment.
- Serve as Engineering SME for Change Control process for process equipment changes.
- Develop and execute engineering tests, FATs, SATs and commissioning test plans.
- Support validation activities (IQ/OQ/PQ) and exceptions encountered during execution.
- BS degree in Process/Biochemical/Biomedical Engineering or related engineering degree.
- 6+ years of experience in engineering and/or facilities operations in GMP environment.
- Expertise in GMP process equipment, ideally Single Use bioprocessing and support systems.
- 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.
- Good analytical and troubleshooting skills to solve problems and generate improvement.
- Excellent interpersonal, communication and presentation skills.
- Demonstrated ability to operate in a fast-paced environment, collaborating across multiple stakeholder functions, regulators, and external clients.
OmniaBio Inc. 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.
OmniaBio Inc. 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.
- Pay Type Salary