The CQV Engineer will provide specialist commissioning and qualification support for HVAC and Black Utility systems as part of a defined pharmaceutical capital project. The role is delivery-focused, operating within an agreed scope of work, procedures, and project governance.
Scope of Services
* Execute commissioning and qualification activities for HVAC systems, including AHUs, cleanrooms, pressure differentials, temperature, and humidity control.
* Perform CQV execution for Black Utilities such as compressed air, nitrogen, process gases, and vacuum systems.
* Prepare and execute CQV documentation in accordance with approved project procedures, including protocols and reports.
* Support FAT, SAT, and system handover activities in line with the project schedule.
* Verify installation and functional performance against approved design documentation and specifications.
* Identify and document deviations, punch list items, and execution issues in line with established quality systems.
* Interface with Engineering, Construction, Automation, and Quality teams strictly for project coordination and execution purposes.
* Provide technical input and status updates as required by the project management structure.
* Support regulatory inspection readiness activities related to assigned systems.
Required Experience & Skills:
* Proven experience delivering CQV activities for HVAC and Black Utilities on pharmaceutical or life sciences capital projects.
* Strong working knowledge of cGMP, FDA, EU GMP, and relevant industry standards (e.g., ISPE, ASHRAE).
* Ability to work independently within a defined scope of work.
* Strong documentation, execution, and compliance focus