Commissioning / Qualification and Verification (CQV) Engineer
Description de l'emploi
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