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.
About The Role
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.
• Valuable 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
📌 Specialist MBR Designer (Hyderabad)
🏢 Novartis India
📍 Hyderabad
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