Senior Process Expert

vor 1 Monat

Langkampfen T, Österreich Novartis Vollzeit

**Summary**:

- Shift Lead II

Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen.

Prozessexperte
- Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die terminliche Durchführung von Prozessen sicherzustellen (Business Continuity); einhaltung von cGMPs, SOPs und anwendbaren Richtlinien und funktionalen Standards (z. B. HSE, NOSSCE) und eine kontinuierliche Verbesserung der Qualität und Produktivitätseffizienz zu ermöglichen.
- Operational Scheduler

Der Operational Scheduler erstellt und führt einen aktuellen Plan für die Aktivitäten im Zusammenhang mit der Fertigungseinheit. Der Operational Scheduler ist verantwortlich für die Entwicklung verschiedener Produktionsszenarien (Laufzeiterhöhung, Prozessänderungen, Hochlauf, Schichtmodellanpassung etc.) sowie die Verbesserung des Planungstools.

Manufacturing Systems Expert
MES Expert bietet technisches Fachwissen zur Unterstützung aller Fragen im Zusammenhang mit elektronischen Chargendatensätzen (eBRs). MES Expert unterstützt den MES-Einsatz, die Implementierung und kontinuierliche Verbesserung der Fertigungseinheiten und bietet routinemäßigen technischen Support in der Werkstatt.
- Technischer Trainer
- Liefert technische Schulungen und bewertete Lernergebnisse für den zugewiesenen Bereich. Kann auch Lerninterventionen entwerfen und entwickeln. Kann auch die Schulung Audit-Antwort für den Standort leiten.

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

- Provide front line support to manufacturing, working with the operative teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Support and coordinate in time execution of equipment and process validations and qualifications, liaising with all the relevant parties at shop floor to ensure accurate execution.
- Coordinate and support process changes (PCC).
- Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
- Perform first line evaluation of product and process related issues, perform root-cause investigations (uncritical, major and critical deviations, OOS, OOE) and implement effective CAPAs.
- Support technology trainings and education programs for production operators and others.
- Act as Subject Matter Expert for Audits.

**Role Requirements**:

- Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry, Pharmacy (or comparable studies), min. Master's degree.
- First experience in the pharmaceutical industry, preferably manufacturing of large molecules or development.
- GMP knowledge.
- Proficiency in English and German (spoken & written).

**Desirable Requirements**:

- Experience in coordination, and coordination of internal and external stakeholders.

**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 € 64.023,54 year (on a full-time basis). In most cases, the actual salary will be 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**:
We are committed to building an outstanding, inclusive work 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

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Befristet (Befristet)

Shift Work

No

**Unterstützungen für BewerberInnen mit Behinderungen**:

  • Senior Process Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    391268BR **Senior Process Expert (f/m/d)**: Austria **About the role** **Location**:Austria, Schaftenau As a **Senior Process Expert**, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines...

  • Senior Process Expert

    vor 4 Wochen

    Langkampfen, Österreich Novartis Vollzeit

    Job Summary:As a Senior Process Expert at Novartis, you will play a critical role in ensuring the execution of processes on-time, in compliance with cGMPs, SOPs, and applicable guidelines. You will provide front-line technical and scientific expert support for all process-specific issues and assume duties as accountable person for manufacturing of finished...

  • Senior Process Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **About the Role**: **Location**:Austria, Schaftenau As a **Senior Process Expert**, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to...

  • Process Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    392736BR **Process Expert**: Austria **About the role** **Process Expert (m/w/d), Schaftenau, Tirol, Österreich** Ca. 10 Millionen! Das ist die Anzahl der Zellen des Startmaterials um unsere biopharmazeutischen Produkte herzustellen. Werden Sie ein Teil unseres Novartis Teams und wirken Sie mit, dieses Material zu verarbeiten, die Produktion zu...

  • Process Expert

    vor 4 Wochen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Process Expert (M/F/d ) Location: Schaftenau, Tyrol, #LI-Hybrid We are seeking a Process Expert (M/F/d ) to help us to ensure execution of processes, and to allow continuous improvements in quality, productivity, and efficiency. This role will work directly with the Process Support Unit and reports to the Senior Process Expert. **About the...

  • Senior Process Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: ~Prozessteamleiter mittlerer/kleiner Standort Beaufsichtigt den täglichen Betrieb innerhalb der Produktionseinheit in einer Weise, die mit einer Kultur der Selbststeuerung (Befähigung und Verantwortlichkeit) vereinbar ist, um qualitativ hochwertige Produkte auf konforme, effiziente und kostengünstige Weise herzustellen und an Kunden zu...

  • Senior Process Expert

    vor 6 Monaten

    Langkampfen, Österreich Novartis Vollzeit

    Location: Austria, SchaftenauAs a Senior Process Expert, you will provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to continuously improving in...

  • Senior Expert Engineering

    vor 4 Wochen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that...

  • Process Expert

    vor 2 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Process Expert (M/F/d) Temporary for 2 years. Location: Schaftenau, Tyrol. We are seeking a Process Expert (M/F/d) to help us to ensure execution of manufacturing processes, and to allow continuous improvements in quality, productivity, and efficiency. This role will work directly with the Manufacturing Team and reports to the Process Team...

  • Process Expert

    vor 2 Wochen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: - Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen. Prozessexperte - Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die...

  • Senior Expert, Biologics Analytical Operations

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    386345BR **Senior Expert, Biologics Analytical Operations (M/F/d)**: Austria **About the role** **Senior Expert (f/m/d), Analytical Operations, Schaftenau, Austria, #LI-Hybrid** As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. This will include investigating the stability behavior...

  • Process Expert

    Vor 5 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Location: Schaftenau, Tirol. Austria #LI Hybrid This is a temporary role, originally foreseen until December 2026. Please keep it in mind when applying. As a Process Expert of the Process Support Unit you will do your best to ensure that the execution of processes is on time, and you will collaborate on high standard compliance. This role...

  • Process Expert

    vor 4 Wochen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: - Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen. Prozessexperte - Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die...

  • Senior QA Compliance Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...

  • Process Expert

    vor 1 Woche

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: - Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen. Prozessexperte - Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die...

  • Process Expert

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: - Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung mit den HSE- und GMP-Regeln durchzuführen. Prozessexperte -Bereitstellung technischer und wissenschaftlicher Expertenunterstützung an vorderster Front für alle prozessspezifischen Fragen, um die terminliche...

  • Senior Expert Science

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Drug Product Development Senior Expert Science & Technology (M/F/d), Schaftenau, Austria, #LI-Hybrid. About the Role: We are looking for a passionate Scientist with a background or interest in Modelling & Simulation to join our team and lead a wide range of activities from formulation and process development to technical transfer and submission...

  • Senior Expert, Biologics

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: Senior Expert, Biologics - Visual Inspection, Analytical Operations, Schaftenau, Austria, Hybrid role, #LI-Hybrid As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. A key aspect of the role will be involvement in Global discussions on the methods and processes for Visual...

  • Senior Expert Science

    Vor 3 Tagen

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: As a Senior Expert you will be part of a team developing new Biologic drugs. Analytical Operations is the team releasing the product for clinical trial and investigating the stability behavior of the drugs. Furthermore, we are validating the methods used for release and will be also responsible for transferring the methods to our commercial...

  • Senior Expert, Biologics Analytical Operations

    vor 5 Monaten

    Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: As a Senior Expert you will be part of a team developing new Biologic drugs and the release of product for clinical trials. This will include investigating the stability behavior of the drugs. The role will be a mix of overseeing development, authoring/completing documentation and working at the bench when necessary. As such, you should be...