Specialist MBR Designer

Novartis India; Hyderabad; Hybrid; INR 800,000 - 1,100,000; Full time

Job summary

Novartis Hyderabad is seeking a Specialist MBR Designer to design and revise Master Batch Records and support MES validation activities. The role includes creating master data in MES and preparing SOPs, work instructions, and training for MES users.

The candidate will manage lifecycle changes to MBRs, master data, and eForms, while collaborating across Novartis sites to ensure process standardization and alignment with global requirements.

Qualifications

• Bachelor’s degree in pharmaceuticals, chemistry or a related technical field.
• 1+ year of MBR design experience in MES PAS-X 3.3 or MES OpsTrakker.
• Experience in the pharmaceutical industry and knowledge of manufacturing processes.
• Fluency in English; German language skills are a plus.

Responsibilities

• Design and revise Master Batch Records (MBRs) and related documents.
• Manage master data configuration and lifecycle changes.
• Act as MES key user at the site and support investigations.
• Enforce standardization and harmonization with global core processes.
• Support validation activities and ERP integration.
• Participate in MES communities of practice.

Skills

MBR design

Team collaboration

English communication

GxP pharma processes

Education

Bachelor’s degree in pharmaceuticals/chemistry or related field

Tools

MES PAS-X 3.3

MES OpsTrakker

Job description

Job Description:

Summary

Location: Hyderabad, India 12 days/month in office

Internal job title: Specialist MBR Designer

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.

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 3.3 or MES OpsTrakker.
• 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!

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.