Senior Engineer, Single-use Systems/Disposables
Invetech
Melbourne, Australia, Asia Pacific
2d ago

This role will be responsible for providing SME technical and strategic leadership on all aspects of single-use disposables specification, design and manufacturing establishment for Cell Therapy applications globally.

Responsibilities :

  • Contribute to integrated design and manufacturing establishment for Cell Therapy single-use disposables
  • Undertake specification, concept design, detailed design including design for manufacturing, design review against specification, and transfer to manufacture for single-use disposable sets
  • Provide specialist skills, advice and direction to Invetech teams within the single-use disposables domain
  • Contribute to creation of standard work in the field of disposables design
  • Contribute to high-value, capable and efficient disposables supply infrastructure (in collaboration with CT Manager Disposables Supply Chain) through building key supplier relationships and aligned processes for development, design and manufacturing establishment with vendors bringing appropriate capabilities and capacity
  • Participate in supplier selection, considering strategic balance of supplier capability / capacity, achievable cost / quality / schedule, and global supply security
  • Oversee manufacturing establishment of disposables with selected vendors, from design handover to qualified supply
  • Support both client-focused project execution and internal product development
  • Provide mentoring and leadership of engineers within the MID group in area of expertise to build personal and group capability.
  • Skills / Experience

  • 6+ years of experience in the design, manufacturing establishment, and introduction to / ongoing use in GMP manufacturing of single-use disposables for therapeutic / biotherapeutic manufacturing in regulated GMP environments, preferably cell, gene and tissue therapies
  • Experience with peripheral materials consistent with the aforementioned application, or experience with plastics for use in medical applications
  • Exposure to the global supplier landscape for the manufacture of single-use disposables for biotherapeutic manufacturing would be desirable
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