Manager, Commissioning, Qualification and Validation (CQV)

at  Omniabio

ABOUT OMNIABIO

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.com to learn more.

POSITION SUMMARY

As Technician II, Facilities HVAC (Heating, Ventilation and Air Conditioning), you will be a key part of the OmniaBio team and will be primarily responsible for the execution of all HVAC and related work orders and preventive maintenance (PM) activities in support of Good Manufacturing Practices (GMP) activities. The position is located at OmniaBio’s Hamilton, Ontario, facility and is site-based, to support 24/7 manufacturing activities. The Technician II, Facilities HVAC, will share routine on-call coverage for after-hours maintenance, as required. Training will be provided at the Canadian Advanced Therapies Training Institute, located at the University of Guelph.

QUALIFICATIONS:

• High school diploma or equivalent required.
• Gas fitter’s license G2 or G3 is an asset.
• Minimum of 3 years of prior industrial HVAC experience preferred.
• Excellent understanding and troubleshooting skills with HVAC, air conditioners and humidification systems.
• Effective knowledge in building control systems.
• Computer skills such as Microsoft Office (Excel and Word).
• GMP and SAP experience.
• Experience in clean room environments.

• Complies with all personnel management policies and procedures, and maintains an organized, clean and safe work area.
• Provides technical input to the creation and revision of PM procedures.
• Leads and provides guidance on all matters related to the building’s HVAC systems.
• Troubleshoots complex breakdown situations and perform repairs.
• Contacts contractors for repairs or PM, and monitors and reviews contractor work while on site.
• Uses the SAP enterprise resource planning software to regularly review outstanding HVAC-related work and PM orders and communicates a clear completion plan to the Supervisor, Facility.
• Completes all required PM and facility maintenance orders in compliance with current GMP/good documentation practices and manufacturers’ recommendations.
• Completes all paperwork in a timely and accurate manner.
• Facilitates the receipt and handover of clean rooms between the Facilities group and the user group.
• Supports other facility work orders, tasks and PM as required.
• Works with user groups on scheduling of maintenance work to avoid disruption of services.
• Reads and interprets equipment drawings, blueprints and schematics.
• Supports continuous improvement and embraces the OmniaBio Operating Model.
• Uses process control system and building management system to identify and report unusual equipment operation, deficiencies or deviations immediately.
• Supports deviation investigations and root cause identification, and recommends corrective and preventive actions.
• Collaborates with cross-functional teams, including the Process Development, Manufacturing Science and Technology, Operations/Manufacturing, Quality Assurance, Supply Chain and Materials Management teams, among others, to coordinate maintenance activities.
• Trains maintenance personnel on equipment PM and operational procedures.
• Supports risk assessments (e.g. failure mode effects analysis, hazard and operability study).
• Identifies and sources spare parts related to HVAC and facility systems.
• Monitors inventory of HVAC and facility consumables, and reports when items need to be ordered.
• Communicates with direct supervisor and uses the SAP inventory system to ensure all critical parts (filters and belts) are in stock and stored properly.
• Completes safety-related action items, hazard recognition and workplace inspection items.
• Accommodates a flexible work schedule that may include shift work, weekends and on-call availability to support operating schedules and/or respond to breakdowns/problems.
• Completes all other relevant duties, as assigned.