Process Engineering Specialist II

Canada Req #142
Wednesday, September 28, 2022

About OmniaBio:

OmniaBio Inc, a subsidiary of Toronto-based CCRM, is a contract development and manufacturing organization (CDMO) producing gene-modified cell therapies and viral vectors, compliant with cGMP standards.

The facility has support from the Government of Ontario, via the Invest Ontario Fund, and is the first project to be funded through the Life Sciences Strategy. The facility will be built in phases with the ultimate goal of building the largest facility of its kind in Canada (over 350,000 sq ft). OmniaBio is Canada’s first commercial-scale CDMO dedicated to cell and gene therapies.

Located on the biomanufacturing campus at McMaster Innovation Park (Hamilton, ON), OmniaBio will catalyze life sciences careers and innovation in Canada while advancing pioneering medicine with the potential to cure, not just treat, many forms of cancer, cardiovascular diseases, Parkinson’s, and diabetes, amongst others. OmniaBio will support a broad range of cell and gene therapy companies globally, enabling pivotal/Phase III and commercial-scale manufacturing.
OmniaBio will complete CCRM’s continuum of process development, clinical and commercial capabilities. CCRM is a leader in developing and commercializing regenerative medicine-based technologies, and cell and gene therapies.

Role Summary:

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.
 

Responsibilities:

  • 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.

Qualifications:

  • Experience
    • 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.
  • Behaviours
    • 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.

Applicants must be legally eligible to work in Canada.


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.

Other details

  • Pay Type Salary
Location on Google Maps
  • Canada