CQV Engineer

Job Title: Senior CQV Engineer Location: Toronto, Canada (Onsite) Job Description: Our client is seeking a Senior CQV Engineer to serve as the primary technical Subject Matter Expert (SME) for a major facility commissioning and qualification project. This individual will oversee and ensure that two external CQV firms properly plan, coordinate, and execute all commissioning, qualification, and validation (CQV) activities in compliance with project and regulatory requirements. This is an oversight and leadership role—hands-on protocol execution is not required. Instead, the engineer will provide technical guidance, review and approve CQV documentation, witness critical execution activities onsite, resolve technical issues, and ensure successful project delivery through effective coordination with internal stakeholders and external vendors. Key Responsibilities: Act as the lead CQV technical SME for facility commissioning and qualification activities. Oversee the execution of CQV activities performed by two external CQV service providers. Review and approve commissioning, qualification, and validation protocols, reports, and supporting documentation. Witness critical CQV execution activities onsite to ensure compliance with project standards and GMP requirements. Identify, troubleshoot, and resolve technical CQV issues, providing guidance to project teams and vendors. Ensure CQV deliverables meet regulatory expectations, quality standards, and project timelines. Collaborate closely with Engineering, Quality, Validation, and Project Management teams throughout the project lifecycle. Drive consistency and best practices across all CQV activities while ensuring inspection readiness and documentation quality.

Serve as the primary technical SME overseeing two external CQV firms to ensure proper planning and execution of facility commissioning and qualification. Review and approve CQV documentation and witness critical onsite activities to ensure regulatory compliance.

Requires a senior-level engineer capable of providing technical guidance and oversight for CQV activities in a pharmaceutical manufacturing environment. Must be able to resolve technical issues and collaborate with internal stakeholders and external vendors.

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Commissioning
• Qualification
• Validation
• CQV Oversight
• GMP Compliance
• Technical Leadership
• Vendor Management
• Protocol Review
• Project Coordination
• Regulatory Compliance

• Engineering
• Manufacturing
• Healthcare
• Management & Leadership
• Consulting

Expérience minimale

5+ ans

Postuler avant le

5 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte