OmniaBio Careers

Description

Department:      Facilities and Engineering

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, Calibration, you will be responsible for the execution of all calibration-related work and preventive maintenance (PM) orders to support Good Manufacturing Practices (GMP) activities at OmniaBio. This role is site-based, to support 24/7 manufacturing activities at OmniaBio’s Hamilton, Ontario, facility. The Technician II, Facilities, Calibration, will share routine on-call coverage for after-hours maintenance, as required. Training for this role will be provided at the OmniaBio-affiliated Canadian Advanced Therapies Training Institute, located at the University of Guelph. 

Responsibilities:

• Complies with all personnel management policies and procedures, and maintains an organized, clean and safe work area.
• Provides technical input to creation and revision of calibration procedures. 
• Leads and provides guidance on all matters related to calibration and instrumentation.
• Troubleshoots complex breakdowns and provides solutions for repairs.
• Contacts contractors for repairs or PM, and monitors and reviews contractor work while on site.
• Organizes off-site calibration activities and services.
• Uses SAP enterprise resource planning (ERP) software to regularly review outstanding calibration PM and communicates clear completion plan to Supervisor, Facilities.  
• Completes all required PM and facility maintenance orders in compliance with current GMP/Good Documentation Practices and within the manufacturers’ recommendations.
• Completes all paperwork in a timely and accurate manner. 
• Facilitates the receipt and handover of equipment between maintenance staff and user groups. 
• Works with electrician to inspect all process control cabinets to ensure proper connection and limit any signal-related issues throughout the facility.
• Ensures that all master instruments are calibrated to meet OmniaBio quality standards.
• Reads and interprets drawings, blueprints and schematics of control loops to ensure proper installation and communication with our process and building control systems.
• Supports continuous improvement and embraces the OmniaBio Operating Model.
• Uses the process control system (PCS) to ensure equipment is functioning as expected.
• Supports deviation investigations, identifies the root cause using a systematic approach, and identifies corrective and preventive actions.
• Collaborates with cross-functional groups, including the Process Science and Analytical 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 calibration and operational procedures.
• Supports risk assessments (e.g. failure mode effects analysis, hazard and operability study).
• Identifies and sources spare parts related to calibration and control systems.
• Monitors inventory and reports when items need to be ordered. Communicates with direct supervisor and uses SAP ERP inventory system to ensure all critical parts (control system components, instruments and sensors) 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, as well as weekend and on-call availability to support operating schedules and/or respond to process problems. 
• Completes all other relevant duties, as assigned. 

Qualifications: 

• Post-secondary education in instrumentation, process control or a related field. 
• Minimum of 3 years of prior industrial maintenance experience, preferably in a pharmaceutical or laboratory environment.
• Knowledge of a wide variety of instrumentation and of occupational health and safety requirements.
• Skilled in using computer software systems such as Microsoft Office (Excel and Word) and a willingness to learn how to use OmniaBio’s building management system and PCS. 
• GMP and SAP ERP experience is an asset. 
• Strong competence in record keeping/organization, database maintenance and spreadsheets. 
• Good understanding of basic electrical and instrumentation principles.
• Ability to troubleshoot electrical circuits and signals.
• Competence in soldering and circuit repair.

Desired Competencies and Behaviours: 

• Strong communication skills.
• Able to work with internal and external partners.
• Possesses integrity.
• Demonstrates resilience and tenacity.
• Diligent.
• Possesses interpersonal awareness.
• Able to persevere through challenging, demanding and changing situations.
• Able to lift or carry 40+ pounds.

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.

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.