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MES and Electronic Batch Record Expert TaSiVa (f/m/d)

Singen (Hohentwiel), Germany

Overview

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Success

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MES and Electronic Batch Record Expert TaSiVa (f/m/d)

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Job ID R0006575 Date posted 03/19/2019 Location Singen (Hohentwiel), Baden-Württemberg

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Job Description

For English see below.

Am Standort Singen errichten wir aktuell ein Gebäude für die zukünftige Dengue Impfstoffproduktion. Diese Position ermöglicht Ihnen die einzigartige Chance beim Aufbau der Impfstoffproduktion dabei zu sein. Dazu suchen wir im Bereich Takeda Singen Vaccine zum nächstmöglichen Zeitpunkt einen MES and Electronic Batch Record Expert TaSiVa (w/m/d).

Ihre Aufgaben

Projektphase:

  • Unterstützung des MES und Electronic Batch Record (EBR)-Teams für die neue Takeda Impfstoffproduktion
  • Aktive Mitarbeit im MES-Projekt am Standort Singen
  • Abstimmung der Aktivitäten mit IT, Engineering und dem MES-Lieferant WERUM
  • Erstellung/ Schulung der relevanten GMP-Dokumente für das MES und eBR (Pas-X)
  • Erstellung/ Validierung/ Koordinierung der EBR-Vorlagen für Fill-Finish wie auch Verpackung

Produktionsphase:

  • Aufrechterhaltung des MES und Ausbau auf weitere Bereiche inkl. eBR
  • Koordinierung der Aktivitäten zur statistischen Datenerhebung von Produktionsprozessen mittels Statistikprogrammen
  • Statistische Auswertung von Produktionsprozessen

Ihr Profil

Sie sind ein Experte in der pharmazeutischen Herstellung, kennen sich mit Herstellprozessen und deren GMP-Abarbeitung (Abweichungen, Changes …) aus. Sie haben Interesse eine neue Produktionsstätte in eine digitale Zukunft zu führen und "Electronic Batch Record" mit einem hohen Automationsgrad zu etablieren.

  • Bachelor oder Master Abschluss im Bereich Engineering (Chemie, Pharmatechnik), Informatik oder Wirtschaftswissenschaften
  • Erfahrung mit einem MES-System in der Pharmaindustrie wünschenswert
  • Sehr gute technische und GMP-Kenntnisse
  • Sehr selbstständige und sorgfältige Arbeitsweise verbunden mit einem hohen Qualitätsbewusstsein
  • Agiles  Mindset
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

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At our Singen site, we are currently erecting a building for future Dengue vaccine production. This position gives you the unique opportunity to participate in the development of vaccine production. We are looking for a MES and Electronic Batch Record Expert TaSiVa (f/m/d) in the Takeda Singen Vaccine division at the earliest opportunity.

Tasks

Project phase:

  • Support of MES and Electronic Batch Record (EBR) team for new Takeda vaccine production
  • Active participation in the MES project at the Singen site
  • Coordination of activities with IT, Engineering and MES supplier WERUM
  • Preparation/ training of the relevant GMP documents for the MES and eBR (Pas-X)
  • Preparation/ validation/ coordination of EWC templates for fill finish as well as packaging

Production phase:

  • Maintenance of the MES and expansion to other areas incl. eBR
  • Coordination of activities for statistical data collection of production processes by means of statistical programs
  • Statistical evaluation of production processes

Your Profile

You are an expert in pharmaceutical manufacturing with knowledge of processes and their GMP processing (deviation, changes, etc.) You are excited about bringing a new plant to the digital future and establishing "Electronic Batch Record" with a high automation level.

  • Bachelor or Master degree in Engineering (chemistry, pharmaceutical engineering), Information Technology, Economics
  • Experience with an MES system in the pharmaceutical industry desirable
  • Very good technical and GMP knowledge
  • Very independent and careful working method combined with a high quality awareness
  • Agile Mindset
  • Very good written and spoken German and English skills

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0006575

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