11 days ago on roche.com

Verification Engineer (Temporary contract for 18 months)

Roche AG

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Verification Engineer (Temporary contract for 18 months)

Verification Engineer (Temporary contract for 18 months)

Switzerland, Basel-Town, Basel

The Department Device Development at F. Hoffmann-La Roche is responsible for the development of medical devices and combination products for R&D portfolio drug products. The department`s activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization and subsequent product care considering required regulatory, legislative, ecological, economical and technical aspects.

Within the department, the Section Verification Engineering is mainly responsible for the generation and management of experimental and cGMP verification activities providing objective evidence that the medical device / combination products perform according to patient`s and technical needs. Thereby, the Section Verification Engineering supports the evaluation, selection, design, development, characterization, and industrialization of medical devices and combination products (e.g., pre-filled syringe, needle safety device,utoinjector, injector pen, infusion pump, new & break-through & platform technology, special packaging).

In this position, your main responsibilities will be:

  • Organizing & conducting experimental characterization and cGMP verification of medical, devices / combination products and primary containers
  • Evaluation, practical development and validation of new test methods & Technologies,
  • Evaluation & implementation of new lab testing equipment,
  • Documentation (plans, protocols, reports) according to cGMP requirements
  • Liaison with; and provide technical support to key customers in development, clinical and commercial phases, e.g., for filling, assembly and packaging operations/sites, quality and regulatory departments, pharmaceutical development (e.g., formulation), supply chain
  • Support technology transfer of medical devices / combination products to commercial sites (specification/method/equipment transfer)
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
    • Technical education, BS or advanced degree in Engineering or Science discipline (pharmaceutical / natural / biomedical / materials science or a related field)
    • Experience in practical testing and characterization of medical devices/combination products, primary packaging or pharmaceutical development (e.g., formulation, analytics), preferably for parenteral drug products
    • Experience of working in Pharma or other closely-regulated environment under cGMP, or similar working practices
    • Appropriate knowledge of legislation, regulation, industry standards and guidance around the area of medical devices / combination products

    Hands on expertise in:

    • Functional / physical testing (e.g., container closure integrity, compression / tensile testing)
    • Dimensional measurements
    • Jigs & fixture design
    • Good knowledge of statistical techniques, risk management, root cause analysis is a plus
    • Very good command of spoken/written English and German
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Technical Development
    • Subfunction Device Development
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/12/03
    • Job-ID 3106514857
  • Get in touch
    Orsolya Kiss +41 61 688 17 85

    Work location: Basel