With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
CSL Behring is a global biotherapeutics leader driven by its promise to save lives.
We are currently looking for a
Senior Device Engineer Primary Packaging and Medical Devices (m/f/d)
In this role you will work with the strategic growth and restructuring of PPMD (Primary Packaging and Medical Devices) Team. You help execute on the strategic focus area’s for PPMD and you are responsible for the selection, evaluation, improvement, qualification, implementation of new existing primary packaging materials, medical devices, and Combination Product for CSL Behring products. Also you provide scientific support to maintain the design of our existing commercially released Combination Products. You coordinate cross-functionally with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain to provide post launch support, including design and supplier-related changes, product complaints, root cause analysis and other compliance projects. Furthermore you execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery device, you develop high-level plans, schedules, resource estimates, and budgets for projects.
You establish and manage key company relationships with suppliers, CRO’s, CMO’s and standardizing Committees, you support supplier audits and due-diligences of suppliers.
You will report directly to the Associated Director Primary Packaging & Medical Devices.
Flexible work hours and options are available; however, the position is expected to have Bern on-site visibility at a minimum of 60%.
In detail, your responsibilities include:
- Maintain knowledge of relevant legislation, regulation, and industry trends in the field of Combination Products.
- Assure that design verification is performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards. Promote data analyses using advanced statistical techniques
- Application of knowledge pertaining to regulatory landscape to ensure standard compliant designs, working to Quality Management Systems (e.g. ISO 13485, 21CFR820, ISO14971)
- Develop and execute Human Factors Engineering plans as per current standards and guidelines (e.g. FDA HFE Guidelines)
- Write and review HF study protocols (formative and summative studies)
- Support strategic thinking for the group in the context of developing/selecting best-in-class drug delivery devices
- Ensure robust device selection, assessment of container-device compatibility and container-drug compatibility for existing and new technologies
- Interface with experts from outside sources, companies, and forums to maintain an understanding of new developments in drug delivery
- Support of reports review of final reports, data, questions for regulatory submissions/filings
- Support with resolving issues arisen from internal quality assessments/audits by preparing appropriate responses and corrective action resolutions
- Supporting the creation, review and/or approve design control documents (i.e. DHF documents)
- Ensuring agreed targets for quality, timelines, costs, and user requirements are met
- Provide effective and transparent communications to team members, colleagues, and other internal and external collaborators
- Present at internal and external scientific
Who you are:
In this role you apply your knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements. With your proactive and solution-driven approach you are a highly efficient team member and you enjoy working in multicultural and international teams.
The below competencies furthermore contribute to your success:
- University degree, in a relevant field of science e.g. engineering, in biotechnology / biochemistry / biology or corresponding qualification based on work experience in a relevant field
- 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
- Strong scientific background in all aspects of primary packaging and drug delivery.
- Experience with regulatory and quality standards
- Experience with test method development, Combination Product Verification Testing, and specification generation
- Highly experienced in working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements
- Maintain an external and strategic focus. Incorporate ideas from outside CSL, and/or the industry, to improve work processes
- Instill personal flexibility, show openness to learning and the flexibility to adjust to new situations. Expand and build capabilities to meet evolving business needs and help others do the same