CSL Seqirus is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department, responsible for leading the development of drug delivery systems and ensuring compliance with regulatory standards. The ideal candidate will have significant experience in drug delivery device development within a highly regulated environment, along with strong collaboration and communication skills
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.
Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of finished product and the successful tech transfer to manufacturing sites to enable commercial strategies.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Principal Engineer for its Drug Delivery Systems and Packaging department, responsible for leading the development of drug delivery systems and ensuring compliance with regulatory standards. The ideal candidate will have significant experience in drug delivery device development within a highly regulated environment, along with strong collaboration and communication skills.
Skills & Requirements
Must-have
Drug Delivery Systems development
Combination Product development
Design Controls and Risk Management
Regulatory and quality standards
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 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