391268BR
Jan 31, 2024
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 and functional standards (e.g. HSE, NOSSCE) and to continuously improving in quality, productivity efficiency.
You will also assume duties and responsibilities as accountable person (“Herstellungsleiter”) for manufacturing of finished product (“Halbfertigprodukt” and “Fertigprodukt”) according to §8 of Arzneimittelbetriebsordnung (AMBO) 2009.
This role will work directly with the Manufacturing Team team and reports to the Process Support Unit Lead.
Key Responsibilities:
Your responsibilities include, but are not limited to:
• Provide front line expert support in the coordination and production of biopharmaceuticals.
• Support of fundamental GMP processes.
• Preparation of production supporting documents and concepts, as well as for internal and regulatory inspections.
• Ensure real time shop floor support as an expert on technical problems and ensuring the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules.
• Identification, initiation, and coordination of improvement projects in the production environment.
• Preparation / execution of training for production personnel regarding industrial hygiene, GMP and safety.
• Technical control of the execution / interpretation of study results as well as provision and evaluation of process relevant data.
• Handling of deviations, implementation / coordination of defined actions as well as implementation of approved change requests.
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 continuously improving in quality, productivity efficiency.
You will also assume duties and responsibilities as accountable person (“Herstellungsleiter”) for manufacturing of finished product (“Halbfertigprodukt” and “Fertigprodukt”) according to §8 of Arzneimittelbetriebsordnung (AMBO) 2009.
This role will work directly with the Manufacturing Team team and reports to the Process Support Unit Lead.
Key Responsibilities:
Your responsibilities include, but are not limited to:
• Provide front line expert support in the coordination and production of biopharmaceuticals.
• Support of fundamental GMP processes.
• Preparation of production supporting documents and concepts, as well as for internal and regulatory inspections.
• Ensure real time shop floor support as an expert on technical problems and ensuring the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules.
• Identification, initiation, and coordination of improvement projects in the production environment.
• Preparation / execution of training for production personnel regarding industrial hygiene, GMP and safety.
• Technical control of the execution / interpretation of study results as well as provision and evaluation of process relevant data.
• Handling of deviations, implementation / coordination of defined actions as well as implementation of approved change requests.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Role Requirements
What you’ll bring to the role:
• Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry (or comparable studies), min. Master's degree.
• 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?
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 € 60.212,18year (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.
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
• Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry (or comparable studies), min. Master's degree.
• 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?
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 € 60.212,18year (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.
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
Operations
LARGE MOLECULES
Austria
Schaftenau
NVS Pharmaceutical Manu. GmbH
Technical Operations
Full Time
Regular
No
