Validation Lead

vor 2 Wochen

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
Our competence center in Schaftenau for state-of-the-art cell culture technology, specializing in the development and production of innovative biologics and biosimilars. Production of thyroid hormones, growth hormones and growth inhibitors.

**About the Role**:

- Responsible and supporting validation activities at Drug Product Schaftenau, i.e. for filling & compounding processes, primary packaging activities (assembly & packaging), cleaning validation
- Support revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
- HT verifications, general verification studies
- Support establishing local procedures & templates for validation activities and contribute to improvements and optimization of concepts/strategies etc
- Providing senior expertise on complex process validation topics
- Presence and support of Health Authorities, internal and customer inspections

**Minimum Requirements**:

- Min 2-3 years of relevant experience in pharmaceutical manufacturing, tech transfer management / manufacturing science and technology / technical development / quality / validation
- University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering, or equivalent experience
- Solid understanding / insights into DP production (aseptic filling) and/or assembly & packaging activities and respective validation activities
- Basic experience in Project Management, good organization and planning skills
- Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
- Excellent relationship / external stakeholder management skills
- Ability to work in a matrix organization
- Excellent written and verbal communication/presentation skills
- Fluent in English, German desirable

**Why Novartis?**

You’ll receive:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:
Join our Novartis Network:
Division

Operations

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Alternative Location 1

İstanbul Kurtköy, Turkey

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

  • Validation Lead

    Vor 3 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Validation Lead (f/m/d), Schaftenau, Austria** >150! That is the number of countries in which we reach our patients and are at the front line for biotechnological products. As part of the Manufacturing Science & Technology team you can make a difference to millions of patients around the world by supporting the introduction, life cycle management and...

  • Product Steward Lead, Manufacturing Sciences

    vor 1 Woche

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Are you a dynamic and innovative professional seeking an opportunity to make a significant impact in the pharmaceutical industry? Join Novartis, a global healthcare leader dedicated to reimagining medicine to improve and extend people’s lives. At Novartis, we believe in creating a culture of continuous learning and growth, encouraging our...

  • Product Steward, Manufacturing Sciences

    Vor 7 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Technischer Transfer-Lead Verantwortlich für Technologietransferaktivitäten auf Standortebene (Within, Inbound und Outbound), einschließlich etwaiger Scale-up - oder anderer Prozessanpassungen. Leitet das technische Transfer-Projektteam vor Ort und arbeitet effizient mit den beteiligten Funktionen zusammen (z. B. Technische Entwicklung,...

  • Analytical Project Lead

    vor 1 Woche

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Analytical Project Lead, LOCATION: Schaftenau, Austria or Mengeš, Slovenia, #LI-Hybrid We are a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe. We are looking for you as an experienced, curious, inspiring Analytical Project Leader (APL) to...

  • Quality Team Leader QA Operations

    vor 2 Wochen

    Langkampfen, T, Österreich Novartis Vollzeit

    390704BR **Quality Team Leader QA Operations (M/F/d)**: Austria **About the role** **Quality Team Leader QA Operations (M/F/d), Drug Substance, Schaftenau** As Quality TL QA Operations you will be providing the Leadership in all quality related matters to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing...

  • Associate Director Science

    Vor 7 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: >200! This the current number of programs in clinical development at Novartis. Many of these projects, which include new molecular entities, as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide. We are a global team of...

  • QA Operations Lead

    Vor 7 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **QA Operations Lead (f/m/d), Quality Large Molecules, Drug Product Schaftenau, Austria** Nr. 1! Take the lead in making Drug Product Schaftenau to be the nr. 1 fill finish site for biologics within Novartis Operations! A QA Operations Lead is responsible to ensure compliance to cGxP standards for our product portfolio and for product release as well as to...

  • 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...

  • 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 Science

    Vor 5 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    We are looking for an Analytical Project Leader to join a global team of highly skilled analytical project managers with presence in all biologics technical research and development sites of Novartis in Europe. We are looking for you as an experienced, curious, inspiring Analytical Project Leader to join our teams in Austria to support development of...