The job posting is for a Senior Engineer (Drug Delivery Lead) at CSL Behring in Bern, Switzerland, requiring a hybrid working model with mandatory office presence three days a week. The role focuses on developing drug delivery systems and involves cross-functional collaboration, project leadership, and compliance with regulatory standards
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 deliver submission-ready packages for regulators.
CSL Behring operates one of the world's largest plasma collection networks and delivers lifesaving therapies to people in more than 100 countries.
Matching Summary
Match Score: 85
The job posting is for a Senior Engineer (Drug Delivery Lead) at CSL Behring in Bern, Switzerland, requiring a hybrid working model with mandatory office presence three days a week. The role focuses on developing drug delivery systems and involves cross-functional collaboration, project leadership, and compliance with regulatory standards.
Skills & Requirements
Must-have
7 years drug delivery device development
ISO 13485 ISO 14971 21 CFR 820 compliance
Design History File compilation and maintenance
EU MDR regulatory requirements knowledge
Root cause analysis and tolerance analysis
Nice-to-have
Respiratory drug delivery background
Matrix organization project leadership
Strong cross-functional collaboration skills
Self-motivated independent work style
Key Requirements
Masters or PhD in Biomedical Engineering
Minimum 7 years in drug delivery device development
Experience in combination products for respiratory delivery