For our client, one of the worldwide leading manufacturers of measuring instruments and test assays for clinical diagnostic and life science, we are currently looking for this permanent position near to Frankfurt:

Staff Validation Engineer (m/w)

Vertragsart: Festanstellung

Auftragsnummer: A441-714

Startdatum: 01.06.2018

Einsatzort: Hessen

Job-Beschreibung:


Ihre Aufgaben:

  • Planning and monitoring of validation and qualification projects and their implementation
  • Creating validation strategies, validation protocols and validation reports to perform IOPQ for equipment and process
  • Business leadership in validation projects; support other functional groups in assisting in the processes validation and software applications
  • Responsibility for the development and maintenance of the documents for validation according to the requirements of international standards and regulations such as ISO 13485:2016, ISO 14791-2007 and 21 CFR 820
  • Create policies and instructions and ensuring GMP-compliant documentation
  • Creating and training of quality-related procedures and processes

Ihre Qualifikationen:

  • Bachelor’s degree in Chemical, Mechanical or Biomedical Engineering or other similar baccalaureate degree, master degree is an advantage
  • 5 or more years of relevant experience in process validation within a regulated industry
  • Good understanding of validation methodologies with ability to evaluate system specifications and requirements for completeness and testability
  • Able to generate test protocols and procedures from specifications and to execute test procedures manually, with minimal guidance
  • Analysis of measurement data; creating failure statistics; Experience in Statistics / Engineering Analysis
  • Experience with FDA or other Regulated Process and ISO standard such as 13485:2016 and 21 CFR 820 is highly desirable
  • Knowledge of GMP and GDP is required
  • Must have good written and oral communication skills in English and German