Expert Medical Device Testing Laboratory

Vor 6 Tagen


Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
LOCATION: Schaftenau, Austria
TYPE: Hybrid working, #LI Hybrid

At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery systems our patients could not get their medicines.

As a member of the laboratory team of experts you will generate physical/mechanical/functionality analytical data to characterise and assess quality and stability of our vials, syringes, autoinjectors etc, and respective drug-device combination products. You will contribute to data assessments with project teams, to out-of-spec investigations and method improvements etc.
The laboratory is at the beautiful location Schaftenau in Tyrol, a vibrant site with both development and manufacturing of a broad range of Novartis portfolio happening here.

If you enjoy being in the lab, testing, and the mix of engineering and the medical device area, we would like to hear from you.

**About the Role**:
Your responsibilities include, but are not limited to:

- Designing, planning and performing laboratory functional testing of parenteral medical devices and drug-device combination products, including vials, syringes, needle-safety devices, auto-injectors, on-body pumps, and innovative containers and devices for special drugs like gene therapy and radio-ligand therapy
- Measuring key parameters like injection forces, injection times, dose accuracy, physical dimensions, container closure integrity, with state of the art equipment like customized tensile testers, computer tomograph, coordinate measurement machines, mass extraction etc
- Generating and reviewing test reports
- Contributing to qualification and maintenance of analytical equipment
- Supporting method development, validation and transfer
- Participating in root cause investigations for complaints or out of spec results
- Writing/reviewing lab related SOPs.
- Collaborating with other functions in development to ensure strong analytical data-packages for drug-device combination products

**What you’ll bring to the role**:

- Higher technical secondary school (e.g. HTL) or apprenticeship and several years of experience, or Bachelor’s or Master's degree in engineering or natural sciences (or equivalent)
- Experience working in a laboratory gained in a university or industrial setting, preferably in the medical device or pharmaceutical area
- A strong interest or the desire to learn the multidisciplinary area of medical devices and combination products.
- Collaborative spirit, self-driven attitude, high level of learning agility
- Strong communication / negotiation skills, listening skills, the ability to actively reach out and the ability to understand and connect across functions
- Excellent skills in English, verbal and written. Other language skills, e.g. German are advantageous.

Adjustments for Applicants with Disabilities:
Division

Development

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


  • As&t Expert

    Vor 2 Tagen


    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Responsible for managing all analytical aspects with focus on Medical Devices and functional testing within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted...

  • Senior Expert

    vor 2 Wochen


    Langkampfen, T, Österreich Novartis Vollzeit

    394730BR **Senior Expert - Device Project Analyst (f/m/d)**: Austria **About the role** **Location: Schaftenau, Austria, Hybrid Working #LI-Hybrid** **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact...

  • Senior Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact person & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all...

  • Medical Device Expert

    Vor 5 Tagen


    Kundl, T, Österreich Sandoz Vollzeit

    Medical Device Expert (d/f/m) | Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: **About the Role**: **Major accountabilities**: - You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance. - Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **Quality Specialist Medical Devices (f/m/d), Schaftenau, Austria** 80 products in the pipeline, innovation concepts and increasing impact on the overall NVS technical development portfolio! As part of our QA Team, you will support us in actively mastering this challenge every day with the latest technologies and thus achieving the goal of making...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide. As part of our team, you will be supporting introduction of new...


  • Langkampfen, Österreich Novartis Pharma GmbH Vollzeit

    Senior Expert Container Closure Integrity (m/f/d) Flexible Arbeitszeiten Home Office Teilzeit möglich Überblick Novartis sucht eine Person als Senior Expert - Wissenschaft & Technologie. Du arbeitest im Bereich Verpackung und Testung. Du brauchst Erfahrung in der Prüfung von Behälterverschlüssen. Wichtig sind Teamarbeit und Projektmanagement. Das...

  • Associate Director

    vor 4 Wochen


    Langkampfen, Österreich Novartis Pharma GmbH Vollzeit

    Summary #LI-HybridInternal job title: Associate Director - Science & TechnologyLocation: Schaftenau, AustriaAbout the RoleKey Responsibilities:• As a member of global CMC analytical subteam and device subteam for your project(s), you are the contact person & coordinator for all project-specific analytical tasks related to functional attributes of...

  • Senior Expert

    Vor 2 Tagen


    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: ~Entwerfen, Planen, Durchführen, Interpretieren und Berichten von Ergebnissen wissenschaftlicher Experimente zur Vorbereitung und rechtzeitigen Abgabe von Arzneimittelsubstanzen (DS), Arzneimitteln (DP), Prozessen und Verfahren. Leitung und Verwaltung aller Projekt-/lokalen Netzwerkaktivitäten, Unterstützung/Coaching von Teammitgliedern,...