Job description
Mission Description
We are launching a large-scale validation initiative for a new ordering and production system. This project will support the qualification of critical equipment and software within a regulated Life Sciences environment.
The system implementation includes:
* Integration with PROD: pH Connectivity
* QC: Filter Tester, soluVPE, Nova, small-scale analytical equipment
* Software qualification linked to equipment functionality
The team will support key project milestones:
* Support in writing User Requirement Specifications (URS)
* Execution of Design Qualification (DQ)
* Support during system ordering and commissioning
Profile Requirements
Mandatory:
* Proven experience in equipment qualification in a GxP (pharmaceutical, biotech, or medical devices) environment
* Hands-on knowledge of qualification processes for:
o pH connectivity systems
o Filter testers
o soluVPE
o Nova systems
o Small-scale analytical equipment
* Familiarity with software qualification linked to equipment systems
* Strong understanding of validation lifecycle (DQ, IQ, OQ, PQ)
* Fluent in Dutch (written and spoken) – essential for local coordination
* Proficient in English
* Ability to work on-site 5 days/week (with only 1 day possible exception)
Preferred (Plus):
* Experience in writing URS and supporting design qualification
* Background in laboratory equipment qualification
* Knowledge of automated ordering or production systems