Specialist MBR designer

Band

Level 3

 

Job Description Summary

Location: Targu Mures, Romania #LI-Hybrid 12 days/month in office

Internal job title: Specialist MBR Designer

This role is based in Targu Mures, Romania. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the Role:
The Specialist MBR Designer will be responsible for designing and revising Master Batch Records (MBR) throughout both project deployment phases and ongoing site operations, as well as supporting MES validation activities, creating master data within the MES, preparing Standard Operating Procedures (SOPs) and work instructions, and delivering MES training.

 

Job Description

Key Responsibilities:  

• Manage Lifecycle changes of Master Batch Records (MBRs/GMBRs/eForms/Parameter Value List), including minor and major changes.

• Take care of Master data configuration and lifecycle changes (e.g., equipment master data, configuration specification lifecycle updates).

• Act as key user for MES at the manufacturing site supporting investigations of incidents and problem solving.

• Enforce process standardization and harmonization in alignment with global core processes and library elements, where applicable.

• Support validation activities, including Operational Qualification and Performance Qualification for master data lifecycle changes and integration to ERP.

• Participate in MES communities of practices.

Essential Requirements:

• Bachelor's degree in pharmaceuticals, chemistry or another relevant technical field.

• 1+ years of experience in MBR design in MES PAS-X 3.1.8 or PAS-X 3.3.

• Experience in the pharmaceutical industry and knowledge of manufacturing processes.

• Good collaboration, teamwork and interpersonal skills as the role entails working across the Novartis sites.

• Excellent communication, with fluency in English. Other languages such as German are a plus.

Desirable requirements:

• Experience in biomanufacturing processes would be advantageous

• Experience with L2 integration

• Fluency in German language

​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.

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

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

Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Skills Desired

Analytical Thinking, Communication Skills, Requirements Analysis, Requirements Gathering