(Fixed Term) Specialist, Validation (CQV)

The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. In Laval, Moderna’s long term partnership with the Government of Canada is strengthening the country’s pandemic preparedness. Our mRNA vaccine manufacturing facility will support rapid access to respiratory vaccines produced domestically. Through local talent development and research collaboration, we are building a strong mRNA ecosystem in Canada. Join us in shaping the future of biotechnology and healthcare innovation. Reporting to the Director, Engineering & Facilities, this role is central to sustaining the validated state of GMP systems across a cutting-edge manufacturing environment. You will execute and support Commissioning, Qualification, and Validation (CQV) activities across facilities, utilities, equipment, and processes, ensuring operational readiness and compliance. Working as an individual contributor, you will collaborate cross-functionally while leveraging digital and emerging technologies—including opportunities to engage with AI-driven validation and data integrity solutions—to continuously enhance validation excellence. Here’s What You’ll Do: Execute commissioning, qualification, and validation (CQV) activities for GMP systems and equipment Support validation of facilities, utilities, systems, and equipment across the site Execute requalification and periodic review activities to maintain compliance and validated state Collaborating with Manufacturing, Material Supply, Quality, Engineering, and QC to deliver validation activities aligned with project timelines and regulatory requirements Support deviation investigations, including root cause analysis and CAPA implementation Author and review validation documentation including protocols, reports, and risk assessments Ensure all validation deliverables meet internal quality standards and are inspection-ready Support regulatory inspections and internal audits as required Contribute to continuous improvement initiatives across validation and change control processes Manage and complete quality records such as Change Controls, Deviations, and CAPAs related to validation activities Maintain up-to-date knowledge of regulatory expectations and industry best practices Scope and Impact: Contribute to maintaining site compliance and validated systems in a GMP environment Support multiple systems, equipment, and validation projects simultaneously Operate with moderate autonomy on defined assignments while ensuring high-quality delivery The key Moderna Mindsets you’ll need to succeed in the role: “We obsess over learning. We don’t have to be the smartest we have to learn the fastest.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Bring to the Table B.S. in Chemical or Mechanical Engineering (or related discipline) 4–7 years of experience in CQV within a cGMP manufacturing environment Working knowledge of validation of facilities, utilities, systems, and equipment Experience supporting deviation management and CAPA processes Ability to manage multiple priorities and deliver quality work Strong technical writing and documentation skills Effective communication and collaboration skills This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. As part of Moderna’s commitment to build a sustainable workforce, a minimum of 2 years of work authorization is required for this role. Key Competencies Technical proficiency Attention to detail Problem-solving Collaboration Quality and compliance mindset Communication skills Rémunération et avantages sociaux Chez Moderna, nous croyons que lorsque vous vous sentez au mieux de votre forme, vous pouvez donner le meilleur de vous-même. C’est pourquoi nos avantages sociaux m ... (truncated, view full listing at source)