Process Expert Drug Product 80
vor 1 Tag
Switzerland, SteinLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen entwickeln, die anderen Unternehmen helfen, Menschen zu helfen. Im Gegenzug steuern unsere Mitarbeitenden ihre Karriere selbstständig. Denn ihre Ideen, ob gross und klein, verbessern die Welt. Und das ist die Art von Arbeit, an der wir Teil haben möchten.
Für Drug Product Services (DPS), unseren erfolgreichen Zweig der Contract Development and Manufacturing Organisation (CDMO) mit Sitz in Basel und Stein, Schweiz, haben wir spannende Möglichkeiten am Standort Stein. Werden Sie Teil einer Gruppe, die es ihren Kunden ermöglicht, einige der größten Herausforderungen in der Patientenbehandlung zu meistern, und bewerben Sie sich bei uns als Process Expert Drug Product.
**Ihre Aufgaben**:
- Unterstützung bei der sicheren und termingerechten Ausführung von Chargen unter Einhaltung der Qualitätsanforderungen
- Bereitstellung von technischer und verfahrenstechnischer Unterstützung an vorderster Front in Zusammenarbeit mit den Produktionsteams, den Anlageningenieuren und QA Operations
- Initiierung und Durchführung von Projekten zur Prozessverbesserung
- Förderung und Unterstützung der Einführung neuer Technologien/Ausrüstungen
- Leitung von prozessbezogenen Untersuchungen und kritischen Abweichungen, Unterstützung bei der Entscheidungsfindung in Produktionsfragen und Umsetzung von CAPAs sowie Durchführung von CAPA-Wirksamkeitsprüfungen
- Anwendung wissenschaftlicher und statistischer Kenntnisse zur Analyse von Daten, um ein Verständnis für den Prozess zu schaffen und die Ursachen von Produkt
- und Prozessfehlern zu ermitteln
- Aufrechterhaltung der zugewiesenen Prozesse/Ausrüstungen auf dem Niveau der Inspektionsbereitschaft
- Bereitstellung der erforderlichen Unterstützung, sowie Vertretung bei internen oder externen Audits
- Überprüfung von Chargenprotokollen
**Ihr Anforderungsprofil**:
- Ausbildung oder Bachelor-/ Masterabschluss im Bereich Pharmazeutische Technologie, Maschinenbau, Medizintechnik, Pharmazie oder gleichwertiger wissenschaftlicher Abschluss
- Erfahrung auf dem Gebiet der Herstellung steriler Drug Product-Arzneimittel
- Erfahrung mit dem Hochfahren neuer Produktionslinien
- Fliessend in Deutsch und (verhandlungssicher) in English
- Vertrautheit mit GMP-Anforderungen, Qualitätsverfahren und SOP-Ausführung
- Gute Kommunikationsfähigkeiten und Interaktion mit einer Vielzahl von Schnittstellen innerhalb der Organisation und in der Produktion
Lonzas Produkte und Services wirken sich täglich positiv auf Millionen von Menschen aus. Für uns stellt dies nicht nur eine grosse Ehre, sondern auch eine grosse Verantwortung, dar. Wie wir unsere Geschäftsergebnisse erreichen ist für uns genauso wichtig wie unsere Erfolge selbst. Bei Lonza wird Respekt grossgeschrieben und wir schützen sowohl unsere Mitarbeiter als auch unsere Umwelt. Erfolg für uns bedeutet moralisch vertretbarer Fortschritt.
Menschen werden Teil der Lonza, um herausfordernde und komplexe Problemstellungen durch kreative und innovative Ansätze im Bereich Life Sciences zu lösen. Im Gegenzug bieten wir die Zufriedenheit, die mit der Verbesserung des Lebens auf der ganzen Welt einhergeht. Die Zufriedenheit, die damit einhergeht, einen sinnvollen Unterschied zu machen.
- Reference: R60344
- Apply
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