Senior Engineer, Drug Delivery Lead
CSL
full-time
Posted on:
Location Type: Office
Location: Bern • Switzerland
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Job Level
About the role
- 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).
Requirements
- 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.
Benefits
- For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Design ControlsRisk ManagementISO 13485ISO 1497121 CFR 820Design History Filesdesign verificationdesign validationclinical trial supportcommercial manufacture support
Soft skills
leadershiporganizational skillscommunication skillscollaborationindependenceself-motivation