CSL Behring is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department, focusing on the development of drug delivery systems and combination products. The ideal candidate will have extensive experience in drug delivery device development and strong collaboration skills across various functions in a highly regulated environment
Job Summary
Responsible for bringing new Drug Delivery Systems through the development process, involving significant cross-functional interactions.
Apply expertise in Design Controls, Risk Management, EU MDR, and compilation of Design History Files for device/container/packaging performance.
Author and review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
Matching Summary
Match Score: 85
CSL Behring is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department, focusing on the development of drug delivery systems and combination products. The ideal candidate will have extensive experience in drug delivery device development and strong collaboration skills across various functions in a highly regulated environment.
Skills & Requirements
Must-have
Drug Delivery Systems development
Combination Product development
Design Controls and Risk Management
Regulatory submissions for combination products
Primary packaging materials evaluation
Technical Lead for biological/drug-device combination product development
Nice-to-have
Promote a culture of continuous improvement
Advanced statistical techniques for data analysis
Cross-functional collaboration and influence
Key Requirements
At least 5 years in drug delivery device development
Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or related field