Description
We are looking for a
Method Validation Engineer (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Development of a new testing method
- Roll-out the statistical assessment required for method validation
- Provide technical and statistical know-how to ensure validation and transfer to production site of new testing method
- Follow GMP and cGMP requirements for testing laboratory
- Participate in teams to assist in the realisation of necessary improvements to process related issues
Your qualifications
- MSc in mechanical engineering or any in other related field
- Experience in development of medical devices and/or combination products
- Experience in development and validating physical test method
- Deep knowledge of statistical tools used for method validation and transfer such hypothesis tests, sample sizing, normality check, GR&R
- Knowledge of ISO 13485, FDA CRF 21 Part 820, GMP and cGMP
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Qualifizierung