CSL Behring is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department. The role involves overseeing the development of drug delivery systems and collaborating with various stakeholders to ensure the successful execution of projects in a highly regulated environment
Job Summary
Responsible for the 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.
Application of expertise in Design Controls and Risk Management (ISO 13485, ISO 14971, and 21 CFR 820), EU MDR requirements, compilation and maintenance of Design History Files, design verification and validation, and clinical trial/commercial manufacture support.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
Match Score: 85
CSL Behring is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department. The role involves overseeing the development of drug delivery systems and collaborating with various stakeholders to ensure the successful execution of projects in a highly regulated environment.
Skills & Requirements
Must-have
Drug delivery device development
Combination product development
Design Controls and Risk Management
Regulatory submissions support
Technical lead for biological/drug-device products
Nice-to-have
Promote a culture of continuous improvement
Advanced statistical techniques for data analysis
Cross-functional collaboration
Key Requirements
At least 5 years in drug delivery device development
Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or related field