Process Expert

vor 4 Wochen

Kufstein District, Österreich Novartis Pharma GmbH 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).
  • 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.



Desirable Requirements:

  • Experience in coordination, and coordination of internal and external stakeholders.
  • German knowledge will be an advantage.



You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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 €58.199,96/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:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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