Process Expert (m/f/d) - Temporary

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

Major accountabilities:

Your responsibilities include, but are not limited to:

• Provide front line expert support and organizational agility in the coordination and production of biopharmaceuticals (e.g. writing of deviation reports, implementation of CAPAs, participating in change and project management).
• Support of fundamental GMP processes in a fast-paced environment in close collaboration with stakeholders like e.g. QC, QA, Tactical Manufacturing, Automation and Engineering.
• Preparation of production supporting documents (e.g. MBRs, SOPs, Risk Assessments)
• Ensure real-time shop floor support as an expert on technical problems and ensuring the completion of all production operations on time, living up to a high-quality standard in accordance with given documentation and in compliance with GMP standard
• Results driven identification, initiation, and coordination of improvement projects in the production environment and within production storage
• Preparation and execution of trainings for production personnel regarding e.g. GMP and safety aspects.
• Support and direct participation in internal and external health authority inspections.

Minimum Requirements:

• Completed studies in the field of Biotechnology, Molecular Biology, Microbiology, Chemistry or similar (or comparable studies), min. Bachelor's degree with three years of professional experience; Master's degree with one year of professional experience or PhD
• Work experience ideally gathered in the pharmaceutical industry.
• Proficiency in German and English (spoken & written).

Desiderable Requirements:

• Knowledge of USP, DSP, Supply Chain or first experience in these field.
• GMP and/or automation knowledge.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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 € 58.199,596 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:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] 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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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

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