Team Lead Device & Packaging Transfer NOVJP00029423 (m/f)

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Beschreibung


  • As a modern company, our client manages to constantly develop further and break new ground.

Team Lead Device & Packaging Transfer NOVJP (m/f)

Reference: -en
Start: asap
Duration: 6 MM++

Main tasks:
  • Provide technical expertise from commercial point of view during device development stages and process commercialization
  • Support Launch Site Decisions at e.g. PAC by providing analysis of technology, capacity, skills by performing interfunctional evaluations
  • Make recommendation to PAC for assembly and packaging site selection
  • Manage technical launch activities (process, technology, capacity, recources) for assembly and packaging at involved sites
  • Define and monitor project scope and timing
  • Assure that all activities are performed acc. to current processes and standards (GMP, HSE, Regualtory)
  • Member of the BTDM device development subteam, validation team and supply support team
  • Perform Due Diligence initiatives and deal negotiations for selected in-license and out-license projects
  • Act as a manufacturing representative during device development stages (design control)
  • Support site engineering in defining assembly and packaging equipment design / qualification related to transfer / launch products


Main qualifications
  • PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
  • Experience in manufacturing / manufacturing science and technology / technical development/Quality in assembly & secondary packaging projects
  • Strong knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
  • Fundamental understanding of standard device/packaging analytical testing
  • Expert in reviewing and writing technical reports
  • Knowledge regarding design control, documentation, risk management and processes such as DMR, DHF, pFMEA, Design Verification, and URS
  • 21 CFR part , 21 CFR part 4/820 and ISO 13485 knowledge, ISTA, ASTM, EMA medical device directive
  • Willingness to travel for short and long distance
  • Fluent in English, other languages beneficial
  • Flexibility in working hours due to globally located projects / manufacturing sites
  • Intercultural skills to work in a global environment


Main advantages:
  • A very renowned company
  • A city with a high quality of life that perfectly embraces both modern and traditional values
  • A highly motivated team and an open way of communication



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

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Start
ab sofort
Dauer
6 MM++
(Verlängerung möglich)
Von
Hays AG
Eingestellt
13.02.2019
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1718811
Vertragsart
Freiberuflich
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