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AbCellera

Validation Engineer at AbCellera

VancouverFull-timeManufacturing Facilities and EngineeringPosted 8 days ago

About the Role

<p>Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.</p> <p>We are looking for a Compliance/Validation Engineer to join the Engineering Asset Management team and support execution of CQV (Commissioning, Qualification, Validation) and engineering compliance activities, in alignment with regulatory expectations and Good Manufacturing Practices. This role is for you if you bring hands-on experience in a pharmaceutical or biotech environment, paired with sharp analytical thinking, a keen eye for detail, and the confidence to influence and align cross-functional teams.</p> <p><strong>How you might spend your days</strong></p> <ul> <li>Authoring and reviewing CQV protocols, SOPs, and technical documentation, ensuring everything meets rigorous GMP standards and holds up under scrutiny</li> <li>Leading investigations into deviations and non-conformances, driving CAPA implementation that gets to the root cause and keeps issues from coming back</li> <li>Being a trusted voice for the engineering team during internal and external audits&nbsp;</li> <li>Coordinating and executing engineering and quality change controls, keeping projects moving without compromising compliance</li> <li>Drafting and executing CQV deliverables, from User Requirement Specifications to protocols, summary reports, and periodic reviews, on an electronic VLMS</li> <li>Managing the full lifecycle of engineering drawings and documents through e-systems, bringing structure and precision to everything you touch</li> <li>Performing periodic reviews of all qualified systems at our GMP manufacturing facility to ensure ongoing compliance and performance</li> <li>Shaping how the team measures success by supporting the development and tracking of departmental KPIs</li> </ul> <p><strong>We'd love to hear from you if</strong></p> <ul> <li>You hold a Bachelor's degree in Engineering, Chemistry, or a related life science field, and you've spent 3+ years putting that knowledge to work in a similar role</li> <li>You're comfortable navigating electronic VLMS and QMS platforms, and know how to get the most out of them in a fast-paced GMP environment</li> <li>You're the person who catches what others miss; detail-oriented by nature, with documentation and organizational skills that others rely on</li> <li>You bring a proactive, can-do attitude to problem-solving; when an issue arises, you're already thinking about the solution</li> <li>You thrive in a collaborative team setting and know how to communicate clearly across functions</li> <li>You are familiar with AutoCAD or Revit (this is a bonus!)</li> <li>You're a natural at juggling competing priorities; managing multiple tasks without letting anything slip through the cracks</li> </ul> <p><strong>What we offer</strong></p> <p>AbCellera’s hiring range for this role is CAD $73,000 - $87,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.&nbsp;</p> <p>You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.</p> <p><strong>About AbCellera</strong></p> <p><strong><em>Creating medicines is the most important work we can do.&nbsp;</em></strong></p> <p>We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. <br><br>Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.</p> <p>We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.&nbsp;</p> <p>We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.</p> <p><strong>To apply</strong></p> <p>Please submit your application through our website and refer to <strong>Job ID </strong><strong>23367</strong> in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.</p>