Job Title

Project Lead, Facility & Equipment Validation Location: Bradford (travel to BC as required) Hours: 40 hours per week Employment type: Permanent, Full-time Compensation: $70,000 - $80,000 annually JOB SUMMARY Aurora 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 the impact of proposed changes to the current qualification status (i.e., Change Control); act as subjectmatter expert for FEV to support internal investigations and regulatory inspections. The ideal candidate is a strong communicator with a quality mindset who can work effectively with peers and senior management in a highpaced global environment. They should be flexible, responsive, apply critical thinking, and provide sound scientific rationale for riskbased validation strategies. Prior experience with qualitybased practices in a GMPregulated manufacturing industry (Health Canada, EU) and 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 riskbased 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 daytoday basis, with executing protocols and providing realtime guidance and training of qualification strategy and test plans outlined in the qualification protocol. - Develop qualification and functional testing protocols for critical softwarebased 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 riskbased approach. - Support Reliability and Quality Assurance in the development of internal and corporate policies related to the ongoing 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 processing equipment is considered an asset. - Core understanding and experience with 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 everchanging deadlines, priorities and requirements. - Exceptional analytical, organizational and prioritization skills. - Ability to multitask or focus on detailed problems, and tenacity to drive issues until resolved. - Ability to work onsite daily and travel within Canada and/or Europe to various Aurora manufacturing facilities as required. EEO & ACCESSIBILITY STATEMENT We are committed to equal opportunity and inclusivity. We encourage applicants of all backgrounds. We comply with the Accessibility for Ontarians with Disabilities Act. If you require accommodation during the hiring process, please contact [email protected]. #J-18808-Ljbffr