Our client is looking for a experienced qualification and validation engineer with following responsibilities :
Write, review and report with regard to commissioning, qualification and validation documentation.
Follow-up on suppliers and review supplier documentation (witness, FAT and validation)
Active input to determine best validation strategies
Open communication on validation status - issues have to be discussed
Deliver a final qualified and / or validated state of processes, equipment, utilities and facility, according to the quality requirements
Scope-change management on (pre-)validated equipment and deviation management
In depth knowledge of equipment operation on different access levels (up to technical services) (e.g. recipe management, machine operation).
Execute validation / qualification on equipment and complete validation documentation
Propose ( if required ) possible improvements to the equipment and implement according to project-flow
Training of operators on use of machine
Proven experience in equipment related project execution in a GxP environment and related documentation.
Commissioning and validation-knowlegde for manufacturing equipment (including writing and execution of validation-documentation)
Knowledge of risk-based assessments (FMEA : technical - GxP ).
Experienced with scope-change management and deviations.
Hands-on mentality : like to be on the floor and working on equipment
Fluent Dutch speaker, able to communicate and write in English.
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