Computer System Validation Engineer
Baxter
- Leading validation, CSV and equipment, of a fully revamped downstream manufacturing line.
- Validated the automation and control layer (Rockwell FactoryTalk) together with inline optical inspection for plastic film, winder and chill-roll equipment.
- Validating a parallel project: a new raw-material distribution system feeding the line's hoppers.
- Implemented a digital, AI-based process optimization project with a Lean Manufacturing approach.
- GMP documentation end to end: URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, validation reports, deviations.