CQV Engineer Position
Our organization is seeking a skilled CQV Engineer to join our team. In this role, you will be responsible for the planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) activities for facility, utilities and process equipment.
* The ideal candidate will plan, execute and report on CQV activities for assigned systems, including C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ and where applicable PQ activities.
* This includes preparing, reviewing and approving project documentation, ensuring technical accuracy and adherence to regulatory guidelines.
* You will also support design reviews and system risk assessments with multiple stakeholders, confirming that all vendor documentation executions are compliant with GxP practices.
To succeed in this role, you will need:
* A minimum of a honours degree in an Engineering or Science discipline.
* At least 5 years experience in the biotechnology and/or pharmaceutical industry, in a CQV role.
* Proven experience in authoring, review and execution of CQV activities on a variety of Facility, Utility and Process Equipment.
This is an individual contributor role whereby the individual must be a self-starter with significant professional experience in design, commissioning, qualification and continuous improvement of pharmaceutical facilities, utilities and equipment.