Combination Product Device Development Engineer (5266)
The Life Science Career Network
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Combination Product Device Development Engineer
Our client, a large pharmaceutical organization, is looking for a Combination Product Device Development Engineer for a 12-month contract (with possibility for extension) in Bern.
- Carry out technical activities in the field of Combination Products (i.e. drug delivery devices) for subcutaneous delivery.
- Plan, coordinate and monitor orders autonomously.
- Provide specialist experience in Design Transfer.
- Produce Design Control and Risk Management documents.
- Execute portfolio projects within the agreed time – quality – cost frame resulting in state-of–the-art and competitive Devices and related Combination Products and production processes.
- Provide technical, specification, design control (DDP, URS, DIR, DO, DR, DV&V, DTx, DHF), conformity assessment and risk management (RMP, RA, RMP) deliverables.
- Actively contribute to improvement of Combination Product design, development, customization, specification, introduction, integration, qualification, optimization and technology transfer business processes and procedures.
- Collaborate effectively with partners in Technical Research and Development, Quality, Commercial Manufacturing in developing aligned strategies and concepts for the development of Combination Products for drugs and ensuring seamless handover of projects and aligned development of technologies and knowledge.
- Maintain knowledge of relevant legislation, regulation, guidance, normative requirements and industry trends in the field of Combination Products. Maintain own specialist expertise through exposure, education, training, application. Act as Single Point of Contact (SPOC/SME) for own area of responsibility (leadership, technical discipline and/or technology), supporting business, technical and project questions with data, information, suggestions and professional judgement.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- University of life sciences: Master or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field.
- Minimum of 5 years' relevant pharma industry experience and / or equivalent experience in a relevant academic environment. (Strong scientific background in all aspects of Combination Products and drug delivery).
- 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.
- Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies.
- Fluency in English
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