Qualification Engineer

vor 1 Woche

Basel, Schweiz F. Hoffmann-La Roche Gruppe 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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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