Project Lead, Facility & Equipment ValidationJob Location: Onsite, Bradford with flexibility to travel to BC as requiredHours: 40 hours per weekEmployment type: Permanent, Full-timeCompensation : $70,000 - $80,000 annuallyA LITTLE ABOUT USAurora is proud to be a global leader in the cannabis industry. With a smart strategy, unmatched talent and focus on our long-term success, we believe we have a bright future.
At Aurora, we’re passionate about helping patients improve their lives through high-quality premium medical cannabis under brands they can trust and rely on. Our products, available across Canada, Europe, Australia, and New Zealand, include leading brands like Pedanios, IndiMed, San Raf, Tasty’s, Whistler, Greybeard and CraftPlant.
Our diverse team works passionately across various roles, from manufacturing to corporate positions, and many more, united by our purpose: Opening the World to Cannabis. Enabled by science and empowered by people, for patients and consumers. We collaborate globally, embrace change with courage, stay agile, and treat everyone with compassion. We live our values daily, making a meaningful impact on patients, communities, and our A-Team.
JOB SUMMARYAurora Cannabis is seeking a Project Leader, Facility & Equipment Validation. Reporting directly to the Senior Manager, Facility & Equipment Validation, this role will support multiple production facilities, science labs and cultivation activities; Participate in the development and execution 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 FEV to support internal investigations and regulatory inspections.
The person in this role should be a strong communicator with a Quality mindset 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 with Quality-based practices in a GMP regulated manufacturing industry (Health Canada, EU) as well as a strong knowledge of EU GMP, HVAC systems, critical equipment and instrumentation are essential.
MAIN RESPONSIBILITIES:- Author, execute and review Design Qualification, Site or Factory Acceptance Testing and Qualification protocols for equipment, facilities and systems using a risk-based approach supported by sound scientific rationale and statistically valid sampling plans
- Participate in the development of User Requirements Specification documents for critical process equipment, systems and facilities with an emphasis on ensuring design meets regulatory requirement
- Support Operations personnel on the floor at various facilities on a day-to-day basis, with executing protocols and providing real-time guidance and training of qualification strategy and test plans outlined in the qualification protocol
- Develop qualification and functional testing protocols for critical software-based systems, ensuring compliance with 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, Bradford, Brampton and Pemberton 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 to support GMP compliance
- Support operational/quality investigations and represent FEV during regulatory inspections
- Adhere to Company procedures and policies and comply with EU GMP/GACP 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 and guide support personnel in executing protocols as required
EDUCATION & EXPERIENCE:- University degree in Science, Engineering, or related field
- Strong knowledge of Quality Assurance and experience with Regulatory inspections and electronic Quality Systems, including but not limited to internal audit, root cause analysis, failure mode analysis and impact assessment
- Cannabis & CPG industry experience and familiarity with pharmaceutical or food proce