Senior Primary Packaging Developer

CH  ‐ Vor Ort
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Beschreibung

We have an exciting contract opportunity open for a Packaging Project Leader in Switzerland. The ideal candidates should have good experience in Project Management Primary Packaging development projects.

Experience in working with drugs and devices.

Responsible:

  • Lead the technical development of the packaging and/or drug delivery systems, from early phase up to commercialization.
  • Responsible for leading the collaboration with the internal and the external partners.
  • Provide primary packaging and device expertise in a broader cross-functional drug product development team.
  • Supporting and coordinating the manufacturing of clinical material and the production scale up.
  • Supporting cross functional project teams in the development, review and submission of regulatory dossiers.
  • Managing and monitoring Human Factors Engineering activities.
  • Leading Risk management activities.
  • Planning and monitoring of design verification activities (in-house).
  • Leading and authoring technical documentation.
  • Ensuring a high quality Design History file.
  • Transfer of Design History File to production.

Required:

  • Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
  • Minimum 7 years of experience in leading device development.
  • Strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners.
  • Experience in project/program management of complex projects.
  • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation).
  • Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects.
  • Experience of managing external suppliers.
  • Great communication skills.

Kontak: Luchele Mendes

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Start
01/05/2019
Dauer
01/05/2020
Von
Michael Bailey Associates - Munich
Eingestellt
18.04.2019
Projekt-ID:
1759733
Vertragsart
Freiberuflich
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