Project Lead, Facility

2 weeks ago

Bradford, Canada Aurora Cannabis Full time

**A little about us**

Hi, we’re Aurora Cannabis, and we’re so excited to meet you

We’re a global cannabis company driven by our passion to help people improve their lives. We have a diverse team who bring their best every day so Aurora can be the cannabis provider of choice for patients and consumers. We love our work, and we especially love our high quality, innovative brands that make up the Aurora family - from Aurora, Aurora Drift, San Rafael ’71 and Whistler.

Our people combined with our collective passion for the industry is what makes Aurora a special place to work and defines what we call our “A-Team”. We are a high-performing team of cannabis experts, innovators, and champions, that work, learn and win together. We think **BIG**, act **BOLD** and execute with **PURPOSE **in all that we do, and will stop at nothing to cultivate the ultimate cannabis experience for our community.

Are you an experienced Operations professional interested in dynamic opportunity? Do you thrive in a fast-paced environment where you can challenge the status quo, collaborate with others, and maximize efficiencies? If so, we have the perfect role for you

We’re looking for a dynamic professional to join our Operations Team in the role of Project Lead, Facility & Equipment Validation. Reporting directly to the Senior Manager, Facility & Equipment Validation, you would support multiple global production facilities, science labs, and food production activities; Manage 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.

**As a Project Lead, Facility & Equipment Validation you will**
- Author, execute and review 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 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 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 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 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
- University degree in Science, Engineering, or related field
- Cannabis & CPG industry experience is considered an asset
- Core understanding and experience in Quality Systems, Regulatory inspections and project management

**Bonus point if you have**
- Strong 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
- We would like to thank all applicants for their interest but only those selected for an interview will be contacted.

**Why you’l

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