Manager, CQV (Installation, Commissioning, Qualification and Validation)Location: Edmonton, Alberta
Employment type: Full-time, temporary contract through March 2028
Work arrangement: On-site
About the opportunity A growing life sciences organization is seeking a Manager, CQV to support a major pharmaceutical manufacturing facility project. This role will oversee construction, installation, commissioning, qualification and validation activities, ensuring that facilities, utilities and equipment meet project specifications and GMP requirements.
The successful candidate will work closely with the Project Manager, engineering teams, contractors, equipment suppliers and Quality teams to support the facility's transition from construction to operational readiness.
Key responsibilities Construction and installation
- Serve as a subject matter expert for complex construction, installation and CQV activities.
- Collaborate with the Project Manager to coordinate technical activities and resolve project issues.
- Participate in project meetings and support responses to requests for information.
- Oversee construction and installation of cleanrooms, utilities and GMP equipment.
- Review construction QA/QC documentation, identify deficiencies and escalate issues requiring corrective action.
Commissioning
- Review commissioning schedules, plans, procedures and checklists.
- Provide technical guidance on building systems, process systems and equipment.
- Oversee commissioning execution and ensure appropriate documentation is collected.
- Review commissioning reports and confirm that systems are ready for qualification.
- Coordinate and review Site Acceptance Testing with suppliers and engineering teams.
Qualification and validation
- Develop and execute Installation Qualification and Operational Qualification protocols and prepare associated reports.
- Develop Performance Qualification plans and protocols.
- Support qualification of pharmaceutical air systems and building management systems.
- Support GMP risk assessments, including Failure Mode and Effects Analysis.
- Coordinate or support cleanroom smoke studies and media-fill activities.
- Support computerized system validation and qualification of relevant IT infrastructure.
- Work with Quality and technical teams to investigate deviations and resolve qualification issues.
Qualifications - Bachelor's or master's degree in an engineering-related discipline.
- Current Professional Engineer designation (P.Eng.).
- At least five years of relevant experience in process, mechanical or manufacturing engineering.
- Experience supporting commissioning, qualification and validation in pharmaceutical or GMP manufacturing environments.
- Knowledge of cleanrooms, pharmaceutical utilities, building systems and manufacturing equipment.
- Experience preparing and reviewing technical protocols, reports and project documentation.
- Strong understanding of GMP requirements and risk-based approaches to qualification and validation.
To support a fair and efficient hiring process, we may use AI-assisted tools for tasks such as scheduling, note-taking, candidate communications, and assisting our team with aspects of candidate evaluation. These tools are used to
support our recruiters and hiring managers, not replace them. All hiring decisions are made by people, who review and assess candidates using their professional judgment. If you have any questions about how we use AI in our hiring process, we're happy to discuss.
