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Analytical Science and Validation Specialist
vor 5 Monaten
**Arbeitsort**
- Kundl, Tirol
**Umfang**
- Vollzeit
**Wir agieren als wissenschaftlich-technische Berater für unsere Kunden in verschiedenen Ländern (sowohl globale Player in der biopharmazeutischen Industrie als auch Start-Ups und KMUs). Zur Erweiterung unseres Manufacturing Science and Technology (MSAT)-Teams in Kundl bzw. Langkampfen suchen wir Kolleg:innen, die mit uns Projekte in den folgenden Bereichen bearbeiten und leiten**:
- Entwicklung, Transfer und Validierung von analytischen Methoden in der pharmazeutischen Industrie
- Statistisches Monitoring und Life Cycle Management von analytischen Methoden
- Stabilitätsstudien, Comparability-Studien und Biosimilarity-Studien
- Laborgerätequalifizierung
- Unterstützung von Laboren in der analytischen Entwicklung und Qualitätskontrolle
- Unterstützung der Prozess
- und Reinigungsvalidierung sowie Prozesscharakterisierung
**Deine Aufgaben umfassen dabei abwechslungsreiche und anspruchsvolle Tätigkeiten**:
- Projektleitung und -management in bereichsübergeifenden und großteils internationalen Projektteams
- Strategiedefinition, Koordination und Planung für entsprechende Studien (z.B. Methodenvalidierung)
- Verfassen von Risikoanalysen, Studienplänen und - berichten inklusive Erstellung von Analysenplänen
- Erstellung von analytischen Spezifikationen und Testing Monographen
- Probenlogistik und Datenanalysen in der analytischen Entwicklung und Qualitätskontrolle
- Qualifizierung von computerisierten und nicht-computerisierten Laborgeräten inklusive Testdurchführung
- Bearbeitung und Nachverfolgung von Abweichungen
**Dein Profil**:
- Abgeschlossenes Studium in den Bereichen Biochemie, Biotechnologie, analytische Chemie, Molekularbiologie, Mikrobiologie o.ä. bzw. andere gleichwertige Ausbildung
- Berufserfahrung im Bereich analytische Entwicklung oder Qualitätskontrolle von Vorteil
- Wissen über statistische Methoden und die Anwendung entsprechender Software, wie Minitab oder JMP
- Kenntnis wesentlicher regulatorischer Richtlinien (z.B. EMA, FDA, ICH etc.) von Vorteil
- Projektmanagement
- Interesse an Analysenplanung und Probenlogistik
- Gute Deutsch
- und Englischkenntnisse
- Ausgeprägte Kommunikationsstärke und Teamplayer
- Proaktive, eigenverantwortliche und selbstständige Arbeitsweise
- Reisebereitschaft
**Unser Angebot**:
- Sicherer Arbeitsplatz mit abwechslungsreichen und anspruchsvollen Aufgaben
- Freiraum für Eigeninitiative und die Möglichkeit, individuelle Stärken einzubringen
- Wertschätzendes Arbeitsklima mit flachen Hierarchien und gelebter "DU-Kultur"
- Flexible Arbeitszeitgestaltung (keine Kernzeit) sowie Home-Office
- VTU-Academy mit internen und externen Weiterbildungsmöglichkeiten
- Individuelle Karriere
- und Entwicklungsmöglichkeiten (z.B. in organisatorischer Hinsicht als auch als Fach-/Expertenkarriere)
- Sowie weitere attraktive Benefits
- Öffi-Zuschuss (bis zu 300€ jährlich)
- Vorsorgeleistungen und Gesundheitsmaßnahmen (z.B. Unfallvorsorge für alle Arbeits
- und Freizeitunfälle, betriebliche Altersvorsorge, Impfaktionen, Inanspruchnahme von Beratungsleistungen)
- Sabbatical-Möglichkeit (bis zu 3 Monate)
- Freie Getränke an allen Standorten
- Ab dem ersten Tag steht eine moderne, "State-of-the-Art" Arbeitsausrüstung für Dich bereit
- Moderne Büroräumlichkeiten mit gut ausgestatteten Sozialräume/Küchen
- "Leasing-Firmenradl"
- Mitarbeiter
- und Teamevents
- Weitere Corporate Benefits (wie z.B. Mitarbeiterrabatte bei diversen Firmen) u.v.m.
Diese Position ist mit einem Monatsbruttogehalt ab € 3.350;
- (kein All-In) dotiert. Bei entsprechender Erfahrung ist eine Überzahlung vorgesehen.
Wir sind gesetzlich verpflichtet, ein Mindestgehalt in unseren Stellenausschreibungen anzugeben. Das tatsächliche Gehalt richtet sich nach der entsprechenden Erfahrung.
**Kontakt**
VTU Engineering GmbH
Ing.Hermann-Lindner-Strasse 9
A-6250 Kundl
