Principal Engineer, Tech Ops

CSL Limited

Multiple Locations
**
Drug delivery device development
Combination product development
Design controls and risk management
** CSL Limited is seeking a Principal Engineer for their Tech Ops division, focusing on Drug Delivery Systems and Packaging. The ideal candidate will have considerable experience in drug delivery device development and strong technical knowledge in regulatory and quality standards. **

Job Summary

  • Responsible for planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products.
  • Provide in-depth technical advice and guidance beyond DDSP department, working with CMC, Operations, and QC lab organizations to assess projects for design and process risks.
  • Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.

Matching Summary

Match Score: 75

** CSL Limited is seeking a Principal Engineer for their Tech Ops division, focusing on Drug Delivery Systems and Packaging. The ideal candidate will have considerable experience in drug delivery device development and strong technical knowledge in regulatory and quality standards. **

Skills & Requirements

Must-have

  • drug delivery device development
  • combination product development
  • Design Controls and Risk Management
  • regulatory submissions
  • technical advice and guidance

Nice-to-have

  • culture of continuous improvement
  • cross-functional interactions
  • advanced statistical techniques

Key Requirements

  • At least 5 years experience
  • Masters or PhD preferred
  • Experience with regulatory and quality standards

Work Rights

Not specified

Tailored Resume

Cover Letter