Method Validation Engineer (m/f)

Job type:
on-site
Start date:
asap
Duration:
12 MM++
From:
Hays AG
Location:
Basel region
Published at:
10/06/2014
Country:
flag_no Switzerland
Contact person:
Kerstin Werner
Project ID:
786112

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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