Senior Engineer (drug Delivery Lead)

CSL Limited

Bern, Switzerland
Hybrid (3 days onsite, 2 days remote)
7 years drug delivery device development
Iso 13485 iso 14971 21 cfr 820 compliance
Design history files compilation and maintenance
CSL Limited is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, to oversee the development of new drug delivery systems. The role requires significant cross-functional collaboration, project leadership, and compliance with regulatory standards, with a focus on innovative therapies for various therapeutic areas

Job Summary

  • This role is responsible for bringing new Drug Delivery Systems through the development process with considerable cross-functional interaction.
  • The position requires applying expertise in Design Controls and Risk Management to ensure robust designs and deliver submission-ready packages.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives using innovative therapies across multiple therapeutic areas.

Matching Summary

Match Score: 85

CSL Limited is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, to oversee the development of new drug delivery systems. The role requires significant cross-functional collaboration, project leadership, and compliance with regulatory standards, with a focus on innovative therapies for various therapeutic areas.

Skills & Requirements

Must-have

  • 7 years drug delivery device development
  • ISO 13485 ISO 14971 21 CFR 820 compliance
  • Design History Files compilation and maintenance
  • EU MDR regulatory requirements knowledge
  • Project leadership in matrix organization

Nice-to-have

  • Respiratory drug delivery background
  • Combination product development experience
  • Root cause analysis and tolerance analysis
  • Strong organizational and communication skills
  • Self-motivated independent worker

Key Requirements

  • Masters or PhD in Biomedical Engineering
  • Minimum 7 years in drug delivery device development
  • Experience in highly regulated pharmaceutical environment
  • University level education required

Work Rights

Not specified

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