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Jobdetails

Description

As Validation Specialist (m/f), you will be responsible for the qualification and validation of manufacturing equipment, premises, methods, systems and processes.

Tasks

  • Process owner for company’s validation and qualification process
  • manage, maintain and improve validation processes
  • Working with R&D on technical transfer activities
  • Assisting in the identification and development of process control strategies & establishing process parameter / specification relationship for manufacturing to ensure that clinical batches are representative of process
  • For overseeing and guiding the qualification and validation activities for: product manufacturing processes, equipment, systems, methods and facility, and for other items as needed
  • Ensuring the proper documentation of all packaging, cleaning and process validation activities from writing protocols through execution

About Occlutech

Nach Gründung in Deutschland im Jahre 2003 ist Occlutech bis heute eines der führenden Unternehmen auf dem Gebiet der strukturellen Herzkrankheiten geworden. In mehr als 80 Ländern werden ASD, PFO, LAA, PLD und PDA Occluder sowie Zubehör und ein Sortiment an innovativen speziellen Herzimplantatprodukten entwickelt und vertrieben.Mit mehr als 50.000 eingesetzten Implantaten ist Occlutech über ein eigenes Vertriebssystem in Deutschland, Großbritannien, Italien, Frankreich und in Skandinavien sowie über ein starkes Netzwerk mit Vertriebspartnern in der restlichen Welt vertreten. Occlutech verfügt über eigene F&E- und Produktionsstätten in Deutschland, Schweden sowie in der Türkei. Dies erlaubt neben einem schnellen Wachstum flexible F&E-Leistungen und effiziente und rationelle Fertigungsprozesse, die sicherstellen, dass die Produkte bezahlbar bleiben und zugleich neue Investitionen in die Forschungs- und Entwicklungspipeline des Unternehmens ermöglichen.
» learn more about Occlutech

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