Verification Engineer Device and Packaging Development (temporary for 18 Months)

Job description

  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.

In the Device and Packaging Development Department, we are responsible for the development of medical devices, combination products and packaging systems for R&D portfolio drug products. Our 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 responsible for the generation and management of experimental and cGMP verification and qualification activities providing objective evidence that the medical device/combination products/packaging system perform according to patient`s and technical needs. Thereby, we support the evaluation, selection, design, development, characterization, and industrialization of medical devices, combination products and packaging systems (e.g., pre-filled syringe, needle safety device, auto-injector, injector pen, infusion pump, new & break-through & platform technology, blisters, bottles, special packaging).

As a Verification Engineer you will have the following responsibilities:

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You will organize and conduct experimental characterization and cGMPverification/qualificationof medical devices/combination products/packaging systems

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You will evaluate, develop and validate new test methods & technologies

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You will coordinate and conduct test method and technology transfer to clinical/commercial sites

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You will evaluate and implement new, state-of-the-art lab testing equipment including qualification, CSV

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You will document (e.g., protocols, reports, risk assessments) according to cGMP requirements

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You liaise with and provide technical support to key customers in development (e.g., Device Sub-Teams, pharmaceutical development), clinical and commercial operations (e.g., filling, assembly and packaging), quality and regulatory departments, supply chain

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You will translate internal and external cGMP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) in applied operational processes incl. application thereof. This includes the following activities (among others):

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Lead and track change control activities for test methods and lab processes incl. impact assessment on test method validation and compliance of existing lab processes

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Support the development and completion of robust, risk-based medical devices/combination products Design Verification strategies and method validations

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Support development of rationales justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)

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Analyze test data (e.g., design capability, trending, k-value, reliability, DOE)

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Lead and track management of unexpected events (e.g., discrepancies, complaints) for these medical devices/combination products within cGMP regulated area)

As the successful candidate, you will fulfill the following requirements:

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Bachelor of Science or advanced degree in Engineering or Science discipline (pharmaceutical/natural/biomedical/materials/mechanicalscience or a related field)

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2-5 years track record and experience in the development of medical devices/combination products/packaging systems with a focus on practicaltesting/verification/qualification;or pharmaceutical development (e.g., formulation, analytics); preferably for parenteral drug products; and covering the specific responsibilities elaborated above

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2-5 years track record and experience of working in pharma or other closely-regulated environment under cGxP, QSM or similar working practices

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Excellent knowledge of legislation, regulation, industry standards and guidance around the area of medical devices/combination products (Design Control)

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Demonstrable practical knowledge of the following:

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Functional/physical testing (e.g., container closure integrity, compression/tensile testing, dimensional measurements)

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Jigs & fixture design

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Analytical testing (e.g., spectroscopic methods)

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Wet lab skills

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Work with hazardous substances

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Very good knowledge of the following:

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Statistical techniques

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Risk management

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Root cause analysis

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Change/discrepancy management (e.g., Trackwise)

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Methoddevelopment/validation/transfer

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Standout colleague with excellent communication skills

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Very good organizational skills as well as analytical, data-driven thinking

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Excellent documentation practices

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Very good command of spoken/written English and German

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.