Senior Engineer (Drug Delivery Lead)

In this role (hybrid working model with a mandatory three day per week office presence) you will be responsible for bringing new Drug Delivery Systems through the development process. You will have considerable cross-functional interaction, that includes Quality Assurance, Regulatory Affairs, Packaging, CMC, Clinical and Commercial functions. This role reports to the Section Head of Design Assurance in Bern (Switzerland) that is integrated into the global Drug Delivery System function within CSL. The Drug Delivery System function develops combination products and medical devices for the CSL portfolio of drug products.

Specific Accountabilities, Responsibilities and Activities:

• 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.
• Execution of projects within the agreed time, quality and cost constraints, resulting in state-of-the-art drug delivery devices.
• Collaborate with global internal cross-functional expert teams. Provide leadership to ensure the coordination of activities and information between the functions and with external partners.
• 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.
• Provide leadership to Project Team to deliver submission-ready packages for Notified Bodies and regulators, as well as RFI responses.
• Utilise engineering and analysis tools to ensure robust designs and understand device limitations, (e.g., root cause analysis, tolerance analysis, probabilistic design).

• University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field.
• Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment.
• Ideally a background in development of combination products for respiratory drug delivery.
• Ideally experience in project leadership in a matrix organization.
• Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills (English).
• Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies.

CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks,with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary ofCSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company,CSL,headquartered in Melbourne, Australia, employs 32,000 people., CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Areas of Expertise We focus and demonstrate global leadership in three distinct areas-rare and serious diseases; influenza vaccines; and iron deficiency and nephrology. Rare & Serious Diseases CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Vaccines As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries. Iron Deficiency & Nephrology With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives.