Qualification Engineer

vor 1 Tag

Basel, Schweiz Roche Vollzeit

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Die Basel Drug Substance Manufacturing Organisation ist verantwortlich für die Produktion von kommerziellen biotechnologischen Wirkstoffen (Active Pharmaceutical Ingredients, z.B. Avastin und Tecentriq) in modernen und hoch automatisierten Anlagen.

Das Chapter MT&S Qualification & CSV ist zuständig für die Qualifizierung von Standard Systemen und die Validierung der entsprechenden Computer Systeme. Sie versteht sich als eine Service Abteilung für die herstellenden Betriebe.

Der Qualifizierungsingenieur ist verantwortlich für das CSV- und Qualifizierungs-Programm bei Basel DS Manufacturing und die Aktivitäten zur Erhaltung des qualifizierten Status in Zusammenarbeit mit dem Engineering und den Betreibern bei Basel Drug Substance Manufacturing.

Berufliche Möglichkeiten
  • Erstellung von Qualifizierungs- und Validierungsdokumenten (Pläne, Berichte)
  • Bearbeitung von Changes, Deviations, CAPAs, sowie Erstellung von fachlichen Assessments für Stakeholder und Behörden
  • Zusammenarbeit mit Partnern aus dem Site Engineering, der technischen Compliance, den Herstellbetrieben, sowie den IT und QA/QC Abteilungen
  • Arbeit in einem Umfeld mit starkem Teamgeist, zeitnaher und effektiver Kommunikation, Sinn für Dringlichkeit und hoher Motivation, die betrieblichen Ziele zu erreichen
  • Vertretung der Qualifizierung- und Validierungsthemen während Behördeninspektionen sowie in lokalen und globalen Netzwerken, Taskforces, bzw. Projektteams
Qualifikationen & Erfahrung
  • Sie haben fundierte Erfahrung in dem für die pharmazeutischen Industrie relevanten cGMP-Umfeld. Sie sind zudem vertraut mit dem Betrieb und Qualifizierung / Validierung von pharmazeutischen Produktionsanlagen und Prozessen
  • Bachelor, Master oder vergleichbar höherer Abschluss in Naturwissenschaften, Ingenieurswesen, Biotechnologie oder ähnlicher Disziplin
  • Berufserfahrung in der pharmazeutischen Industrie in einer Produktions-, Entwicklungs- oder Qualitäts-Funktion
  • Erfahrung mit Anlagenqualifizierung, Gerätqualifizierung und Computer System Validierung
  • Fliessende Sprachkenntnisse in Deutsch und Englisch

Eine gesündere Zukunft. Das ist es, was uns antreibt, Innovationen voranzutreiben. Die Wissenschaft kontinuierlich weiterzuentwickeln und sicherzustellen, dass jeder heute und für kommende Generationen Zugang zur Gesundheitsversorgung hat. Eine Welt zu schaffen, in der wir alle mehr Zeit mit den Menschen verbringen können, die wir lieben. Das ist es, was uns zu Roche macht.

Roche is an Equal Opportunity Employer.

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