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Aurora is a global leader in the cannabis industry serving both the medical and consumer markets. Headquartered in Edmonton, Alberta, Aurora is a pioneer in global cannabis dedicated to helping people improve their lives. The Company's brand portfolio includes Aurora, Aurora Drift, San Rafael '71, Daily Special, AltaVie, MedReleaf, CanniMed, Whistler, and Reliva CBD. Providing customers with innovative, high-quality cannabis products, Aurora's brands continue to break through as industry leaders in the medical, performance, wellness and recreational markets wherever they are launched. 

 

MANAGER, EQUIPMENT & FACILITY VALIDATION


Aurora Cannabis is seeking a Manager, Equipment & Facility Validation. Directly reporting to the Director, Engineering we are looking for someone who can support multiple global production facilities, science labs, and food production activities. Manage the development, execution and approval of qualification studies for critical equipment, facilities and systems; Assess impact of proposed changes to the current qualification status (i.e. Change Control); Act as Subject Matter Expert for EFQ to support internal investigations and regulatory inspections.  

 

The person in this role should be a strong communicator who is able to work effectively with peers and senior management alike in a high-paced global environment. We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes. The ideal candidate will demonstrate an ability to apply critical thinking and provide sound scientific rationale for risk-based validation strategies. Previous experience in a regulated manufacturing industry (Health Canada, EU) as well as a strong knowledge of GMP, HVAC systems, critical equipment and instrumentation are essential.


ROLE AND RESPONSIBILITIES:

  • Author, execute, review and approve Design (DQ), Site or Factory Acceptance Testing (SAT/FAT), Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols for equipment, facilities and systems using a risk-based approach supported by sound scientific rationale and statistically valid sampling plans
  • Create and/or review and approve commissioning and functional testing protocols to ensure that equipment and facilities, directly or indirectly affecting validated systems are installed and operating according to the design and user’s specifications, and in compliance with regulatory requirements
  • Develop qualification and functional testing protocols for critical software-based systems, ensuring compliance to 21 CFR Part 11
  • Participate in the design review of equipment, facilities and systems and development of User Requirement Specification documents
  • Assess impact of equipment and facility changes to the critical parameters and validated state of the system or facility (i.e. Change Control) for the Markham and Bradford sites and recommend actions such as requalification or functional testing using a risk based approach
  • Support Reliability and Quality Assurance in the development of internal and corporate policies related to the on-going operation and maintenance of equipment, system and facility management
  • Support the development and execution of environmental mapping studies and periodic requalification of Controlled/Classified areas, including seasonal considerations, as well as calibration of critical instrumentation to support GMP compliance
  • Support operational/quality investigations and represent EFQ during regulatory inspections
  • Adhere to Company procedures and policies and comply with EU GMP and Health Canada Cannabis Act, ISO 9001:2008 (Quality Management System), ISO 14001 (Environment Management System) and OHSAS 18001 (Occupational Health and Safety Assessment Series).
  • Oversee external validation consultants, contractors and vendors as required

 

QUALIFICATIONS:

  • University degree in Science, Engineering, or related field 
  • Cannabis & CPG industry experience is considered an asset
  • Experience in Quality Systems, Regulatory inspections and project management
  • Solid knowledge of EU GMP, Change Control, facility design requirements, critical manufacturing equipment and instrumentation
  • Advanced experience with MS Office Suite (Word, Excel, PowerPoint, Outlook, Projects, MS Teams)
  • Demonstrated ability to quickly adapt; maintain focus and a high degree of accuracy while working with complex data in an environment of ever-changing deadlines, priorities, and requirements
  • Exceptional analytical and organizational skills
  • Ability to learn quickly and prioritize appropriately
  • Excellent customer service skills
  • Detailed oriented, self-motivated, team player, with a strong desire to learn new skills and grow
  • Ability to multi-task or focus on detailed problems, and tenacity to drive issues until resolved

 

As a condition of employment, all candidates must provide proof of vaccination against COVID-19 or receive an approved medical or human rights accommodation prior to commencing employment with Aurora. If proof of vaccination is not provided or a request for accommodation is not approved, the offer of employment will be rescinded.

 

We would like to thank all applicants for their interest but only those selected for an interview will be contacted.

 

If applicable, Aurora Human Resources will contact you via your email address provided. We do not contact candidates over Facebook or other Social Media apps. You will never be requested to provide confidential information such as banking information or your Social Insurance Number in the interview process.

 

Aurora is an equal opportunity employer. At Aurora, we are committed to do business inclusively and accommodate applicants with disabilities. If you require accommodation (including, but not limited to, an accessible interview site, alternate format of job posting) during the recruitment and selection process, please let our Recruitment team know. 


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