Method Validation Engineer (m/f)

Job type:
on-site
Start:
asap
Duration:
8 MM++
From:
Hays AG
Place:
the Basel region
Date:
04/29/2015
Country:
flag_no Switzerland
project ID:
894208

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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