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Packaging Technology Transfer Manager

Eingestellt von Michael Bailey Associates - Zurich

Gesuchte Skills: Engineering, Design

Projektbeschreibung

We have an opportunity for experienced engineering to oversee a project of technology transfer for packaging products in combination devices.

This is 6 months project with possibility of extension.

Major tasks.
Provides technical expertise from commercial point of view during device development stages and process commercilisation.
Supports Launch Site Decisions at eg PAC by providing analysis of technology, capacity, skills by performing interfunctional evaluations.
Makes recommendation to PAC for assembly & packaging site selection..
Manages technical launch activities (process, technology, capacity, recourses) for assembly and packaging at involved sites..
Defines and monitors project scope and timing..
Assures that all activities are performed according to current processes and standards (GMP, HSE, Regulatory).
Ensures PAI readiness..
Performs Due Diligence initiatives and deals with negotiations for selected in-license and out-license projects..
Act as a manufacturing representative during device development stages (design control).
Act as a manufacturing representative in the packaging design process for the product portfolio.
Support site engineering in defining assembly & packaging equipment design/qualification related to transfer/launch products

Requirements:
Education in Mechanical Engineering or Pharmaceutical Technology.
Minimum 10 years experience in manufacturing/manufacturing science and technology/technical development/Quality in assembly & secondary packaging projects.
Thorough understanding of product processes
Strong working 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..
Strong Project management skills, strong communication skills.
Knowledge regarding design control, documentation, risk management and processes such as DMR, DHF, pFMEA, Design Verification, and URS. 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485 knowledge, ISTA, ASTM, EMA medical device directive.
Willingness to travel for short and long distance as well as time periods..
Flexibility in working hours due to globally located projects/manufacturing sites. Intercultural skills to work in a global environment.

Please send your CV

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

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Michael Bailey Associates - Zurich