We are looking for a CQV engineer to carry out the commissioning and qualification of new and modified process equipment. These new and modified installations are necessary to be able to produce a new product.
In this position you will work in a project environment and you will be responsible for commissioning, qualification and validation of process equipment and utilities. Activities are carried out according to predefined procedures, standards and current CGMP legislation
Drawing up user requirements together with system owner
Carrying out risk assessments
Drafting, approval and implementation of protocols and reports
Perform FAT and SAT testing
Carrying out commissioning and qualification tests (e.g. installation tests such as P&ID
walkdown, welding check, IO tests and functional tests, electrical schemes walk down)
Reporting and following up on deviations, solving technical problems
Follow-up of changes via the applicable project change control procedure
Follow up on changes in own domain and communicate them to the relevant functions
Overseeing activities performed by third parties
We are looking for CQV profiles with at least 3 years of experience in C&Q
Knowledge of cGMP in a regulated environment is a must
The position requires daily interaction with other project team members (system owner, project engineer, ...), so we are looking for team players with good communication skills.
Knowledge of English is a must, knowledge of Dutch is a nice to have.
Experience with the Kneat application is a plus
Knowledge of (use) DeltaV / BMS is a plus