Qualification & Validation Engineer (m/f/x)
Negotiable
Technical Operations
Frankfurt, Hessen
Permanent
Hybrid

Wir suchen einen engagierten Qualifizierungsingenieur (m/w/d), um die Qualität und Sicherheit von Anlagen sicherzustellen. In dieser verantwortungsvollen Position übernehmen Sie die Qualifizierung und Validierung von Anlagen und Prozessen und tragen somit maßgeblich zur Einhaltung höchster Standards bei.

Diese Aufgaben erwarten Sie:

  • Planung, Durchführung und Dokumentation von Qualifizierungs- und Validierungsaktivitäten für Produktionsanlagen gemäß GMP-Richtlinien
  • Sicherstellung der CSV-Compliance für computergestützte Systeme gemäß GAMP 5 und 21 CFR Part 11
  • Erstellung von Risikoanalysen, Validierungsplänen und -berichten
  • Unterstützung bei der Implementierung und Wartung qualitätsrelevanter Anlagen und Systemen
  • Entwicklung von Arbeitsanweisungen und technischer Dokumentation
  • Koordination und Durchführung von Tests (IQ, OQ, PQ) sowie Unterstützung bei Audits und Inspektionen
  • Enge Zusammenarbeit mit interdisziplinären Teams wie Produktion, Qualitätssicherung

Das bietet Ihnen die Position:

  • Hybrides Arbeitsmodell (2 Tage mobiles Arbeiten pro Woche)
  • Eine wertschätzende Unternehmenskultur und ein kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Die Möglichkeit zur Weiterentwicklung in einem wachsenden Unternehmen
  • 30 Tage Urlaub, Jobrad, Zuschuss zum Fitnessstudio und weitere Benefits

Das bringen Sie mit:

  • Abgeschlossenes Studium im Bereich Ingenieurwissenschaften, Pharmazeutik, Biotechnologie, oder vergleichbare Qualifikation
  • 3 Jahre Erfahrung in der Qualifizierung und Validierung im pharmazeutischen oder biotechnologischen Umfeld
  • Fundiertes Verständnis für GMP-Regularien
  • Eine strukturierte, analytische und lösungsorientierte Arbeitsweise
  • Hervorragende Deutsch- und sehr gute Englischkenntnisse in Wort und Schrift

Informationen über unseren Kunden:
Unser Kunde ist ein innovatives CDMO, das sich auf die Herstellung steriler Arzneimittel spezialisiert. Der Fokus liegt dabei unter anderem auf der aseptischen Abfüllung. Das Unternehmen legt großen Wert auf Qualität und Innovation und ist sowohl national als auch international tätig.

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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.