Computer System Validation Engineer

Vor 7 Tagen

Frankfurt am Main, Hessen, Deutschland agap2 Deutschland Vollzeit

Wir suchen für unser Team in Rhein-Main-Gebiet eine/n Computer System Validation Engineer, um unsere Kunden in komplexen Projekten zu unterstützen und ihre Ziele zu erreichen.

Deine Aufgaben

  • Verantwortung für CSV-Projekte in Bereichen wie Dokumentenmanagement, IT, Pharmakovigilanz und mehr
  • Selbstständige Planung, Steuerung und Umsetzung von CSV-Projekten
  • Erstellung von Validierungsdokumenten und Planung von Tests
  • Erstellung von Arbeitsanweisungen (SOPs) und GxP-konformer Systembetrieb
  • Begleitung von Anpassungen und Veränderungen im Qualitätsmanagement
  • Erstellung von Risikoanalysen, Data Maps und Umsetzung des ALCOA-Prinzips

Deine Kompetenzen

  • Abgeschlossenes Studium in Medizintechnik, Informatik, Pharmatechnik oder vergleichbar
  • Ideal mehrjährige praktische Erfahrung in der Validierung computergestützter Systeme
  • Fundierte Kenntnisse der GMP-Regelwerke und sehr gute Deutsch- und Englischkenntnisse
  • Ausgeprägte Team- und Leistungsorientierung, Flexibilität und Kommunikationsfähigkeit
  • Durchsetzungsstärke und zuverlässiges und selbstständiges Arbeiten

Was uns bei dir erwartet

  • Faire Gehälter mit jährlicher Gehaltserhöhung und gute Work-Life-Balance
  • Steile Karriereentwicklung durch Projektverantwortung
  • Individuelle Begleitung durch einen festen Ansprechpartner
  • Team-Events wie Stammtische, Sommerfeste und Weihnachtsfeiern
  • Mitarbeiterrabatte und EGYM Wellpass
  • Buntes Team mit lockerer Atmosphäre

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