Senior Process Engineer for Medical Devices

Schweiz, Basel-Stadt, Basel Headquarter

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• Job facts

Behind 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 (PTDED)within Roche Pharma Technical Development is responsible for the development and support of medical devices and drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. In this position you are responsible for developing and improving assembly, packaging and manufacturing processes for medical devices and combination products (e.g. Prefilled Syringes, Needle Safety Devices, Auto-Injectors and Patch-Pumps).

This includes the following activities: 

• Lead and execute design transfers for portfolio projects within the agreed time, quality and budget frame


• Collaborate effectively with broad multi-functional internal and external teams (development, manufacturing, equipment engineering, quality, regulatory etc.) in developing strategies and concepts for the manufacturing of medical devices and combination products


• Interface between Device Development and internal / external manufacturing sites


• Support innovation and continuous improvement activities for manufacturing processes


• Responsible for design transfers to internal and external manufacturing sites


• Author of scientific reports, memos and rationales related to design transfer, risk management and control strategy documentation 


• Ensure the qualification and validation of processes and equipment in collaboration with internal validation specialist

Your Qualifications:

• University degree (BSc or MSc in an engineering or related discipline) and more than 5 years’ experience and proven track record in mechanical or process engineering (industrialization) 


• Shown knowledge of medical devices or combination products and industrialization of semi- or fully-automated assembly and packaging processes 


• Sound knowledge of legislation, regulations, industry standards and guidance within the area of combination products and medical devices. (mainly linked to: Design Controls, Product Verification, Design Transfer, Process Validation, Quality Systems) 


• Experience in a wide range of manufacture technologies for low to high volume application (e.g. assembly, packaging, injection molding, machining, marking, printing, gluing, sealing, welding)


• Enthusiastic and high energy self starter teammate with fluent skills in German and English as well as excellent interpersonal skills

Interested? Apply here!

For questions please call the Recruiting Team Switzerland: +41 61 682 25 50

Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.

Technical Development, Technical Development > Medical Device Technology Development

• Who we areBei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.
  
  Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.


• Job facts
  
  
  
  • Location Schweiz, Basel-Stadt, Basel Headquarter
  
  
  • Function Technical Development
  
  
  • Subfunction Medical Device Technology Development
  
  
  • Schedule Vollzeit
  
  
  • Job level Individual contributor
  
  
  • Job type Unbefristet
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2018/09/14
  
  
  • Job-ID 201809-120062
  
  


• Get in touchMrs. Leila Beil


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