Description
For the device development department of our client, an international pharmaceutical company, we are looking for a
Method Validation Engineer (m/f)
Reference: -en
Start: asap
Duration: 8 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure development, validation and transfer of newly developed testing methods for medical devices and combination products
- Accountability for the documentation review of the device development test laboratory
- Supportive function in corrective GMP audit actions
- Provide technical and statistical know-how to ensure validation of and transfer to the production site of new testing methods
- Lead and accountability for development of new testing methods (tooling, risk assessment, first trials)
- Accountability for the statistical assessment required for method validation and method transfer as well for test method development
Your qualifications
- MSc in mechanical engineering or any in other related field
- Deep knowledge of statistical tools used for method validation and transfer
- Experience with developing and validating physical (technical) test methods
- Proven experience in the development of medical devices and/or combination products
- Profound track record and experience in the pharmaceutical, biotech, diagnostics, medical device or healthcare industry
- Knowledge of ISO 13485 (FDA CFR 21 Part 820 and Part 4)
- Profound experience with GMP and cGMP laboratory requirements
- Excellent documentation skills and team work skills
- Excellent IT knowledge
- Excellent command of German and English, both spoken and written
Skills:
- Quality manager
Keywords: Qualitätsmanager GMP engineering biotech pharma diagnostics