Schweiz, Basel-Stadt, Basel Headquarter
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Apply now!PrintBehind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
“Europe Biologics“ (PTDE) supports biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.
The Device Development Department within Roche Technical Development is responsible for the development and product care of drug delivery devices within the Roche product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.
As Senior Device Engineer you will demonstrate considerable cross-functional interaction within the department and with partner functions including Device Quality, Device Regulatory, Global Product Strategy, and Pharmaceutical & Analytical Development, as well as with external suppliers.
Your responsibilities include:
Serving as primary packaging expert on development team to provide the best-in-class container for Biologics drug-device combination products
Authoring design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation
Evaluating and screening new technologies and assessing the market landscape
Applying theoretical and practical engineering knowledge to establish robust technical product requirements
Executing projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
Your Profile
You bring a university level education (engineering degree or related discipline) and a minimum 5 year proven track record in material sciences and development of drug delivery/combination products with experience of working in Pharma (preferred) or other closely-regulated environment
Your further qualifications:
Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions
Demonstrable knowledge of the following: primary packaging and industrial trends, drug container interactions, protein chemistry, drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
Excellent documentation, presentation and interpersonal communication skills, with a very strong command of English language and preferred proficiency in German Strong project management skills and efficient/organized work style
Technical knowledge to support the development of electronic smart/connected medical devices
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be
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