Device & Packaging Transfer Team Lead ( m/w/d ).

Job ID: 10861

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Discipline
Quality/Production
Type of employment
Project Consulting
Company

Our costumer is a global acting biopharmaceutical company based in Austria.

Responsibilities
  • Responsible for Packaging Design Management in global cross functional teams to launch new products and redesign on market products for DD&C
  • Strategic design consultancy for DD&C managed brand
  • Deliver expertise and sound recommendation to further develop and harmonize the Packaging Technology Strategy
  • Responsible to ensure the Packaging Strategy is reflected in development projects
  • Leads packaging design projects
  • Responsible for the design and deployment of standards in materials, formats and processes – issues the global packaging specifications for the NTO manufacturing network
  • Ensures state of the art technical design solutions (incl. feasibility studies, visualizations and prototypes) for commercial, secondary packaging by target oriented management of internal & external resources
  • Delivers technical solutions to address unmet business needs
  • Maintains oversight of projects that are handed over to the internal and external sites for implementation
  • Represents DD&C Global Packaging Design Management in gate review meetings
  • Ensures global documentation and that projects run according to defined processes
  • Creates awareness for potential packaging design improvements, actively contribute to the evolution of process, standards and a design oriented culture
  • Member of the Transfer and Launch projects team with the Packaging and Device TTL and the Device Platform Manager for LCM projects related to secondary packaging design implementation at internal and external NTO sites.
  • Defines Global Guidelines for dimensional and structural standards, conveys the same to production sites and suppliers while ensuring data validity.
Requirements


Education:

  • PhD or Dipl. in Mechanical Engineering or Pharmaceutical Technology

    Languages:
  • Fluent in English and/or German

    Experience:
  • Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects
  • Thorough understanding of product processes and 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 and intercultural skills with ability to work in a global matrix environment
  • Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications)
  • Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive
Region
Österreich