Lead Technician Gmp Operations

vor 12 Stunden

Bern, Schweiz Johnson & Johnson Vollzeit

**Zu den Haupttätigkeiten gehören unter anderem**:

- Praktische Durchführung der Fill&Finish Entwicklungs
- und Produktionsarbeit (Experimente, Produktionen und Tests) inklusive Kontrolle der Batch Dokumentation und gemäss geltenden Richtlinien/Vorschriften (cGMP, SOP, MBR).
- Mitwirkung bei der Herstellung von sterilen Produkten gemäss Produktionsplan: hierbei überwiegend im Bereich Material
- und Equipmentvorbereitung, aseptische Abfüllung, visuelle Kontrolle von abgefüllten Einheiten, Musterzug etc.
- Dokumentation von Experimenten/Produktionen und Ergebnissen gemäss geltenden Vorschriften (GMP compliant)
- Melden und Bearbeiten von Abweichungen des Prozesses sowie Initiieren von Änderungen und Correktive Massnahmen im GMP Bereich
- Diskussion von Ergebnissen, Beteiligung an Fehlersuche und Identifizieren von Verbesserungsmöglichkeiten mit Teamleader/Process Engineer
- Verantwortlich für das Redigieren oder Erstellen von Arbeitsvorschriften und Protokollen
- Mitwirken bei Erstellen und Redigieren von Master Batch Records
- Aktive Beteiligung für kontinuierliche Verbesserung der Prozesse: Erarbeiten von Ideen, Planung/Organisation sowie selbständige Ausführung von Arbeitspacketen
- Organisation der Prozessräume (GMP-Bereich), einschliesslich Sicherheit und Sicherheitsverfahren
- Implementieren neuer Prozesstechniken und Herstellungsequipment
- Unterstützung der Installation und Qualifikation von neuer Ausrüstung
- Unterstützung bei Validierungen, Modifikationen und der Wartung von Einrichtungen
- Verwalten, Bewirtschaften und Instandhaltung von zugeteilten Reinräumen, Einrichtungen und Ausrüstung
- Sample
- und Produktverwaltung in den dazugehörigen Softwares (eLIMS, SAP)

**Qualifications**:
**Wen wir suchen**:

- BSc in verwandter Disziplin (Bereich Pharma/Biotechnologie oder Lebensmittel)
- Erfahrung im hygienischen und/oder sterilen Arbeiten und cGMP Umfeld
- Berufserfahrung in der Biotechnologie von Vorteil
- Erfahrung im Bereich aseptischer Herstellung/Visueller Inspektion von Vorteil
- Teamfähig sowie selbstständige und gewissenhafte Arbeitsweise
- Bewusstsein für die anhaltende Verbesserung der Prozesse
- Die Fähigkeit nach engen und herausfordernden Zeitvorgaben zu arbeiten
- Fliessende Deutsche und Englische Kommunikation in Wort & Schrift
- Bereitschaft zum 2-Schicht-Betrieb (aktuell Tagesbetrieb)

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