Key Responsibilities for MBR Designer
- Application Engineering and Configuration of Electronic Batch Recording for Solid Bulk Manufacturing, Sterile Filling & Compounding, Cold Chain monitoring and Packaging
- Integration with Plant Control Systems /SCADA/OSI PI - MBR configuration for any touch points to interface with Level 2 systems like Simatic Batch, Groninger SCADA , InnoScan SCADA , Seavision LMS, OSI PI
- Site specific requirement analysis and functional specification development
- Gathering requirements for a MBR for a new product.
- Liaising with various product (operations, validation) experts and system member experts (SME's - Automation, SAP etc.) to determine requirements for the new MBR
- Analysis of the business processes/batch records provided by client and building MBR's/EBR's based on these business processes.
- Support site in implementation based on Global templates / Library elements.
- Creation of local process libraries using off the shelf MES product (e.g. Werum PAS|X
- Design and building of the MBR (including GMBR, PMBR as applicable) for Pharmaceutical and Bio-injectable products
- Design and build MBR for Cleaning Operations for Equipment (based on site SOPs)
- Determining updates for Master Data and State Diagrams
- Master data configuration in MES environment.
- Support the screening and interface testing with ERP / GISC (Labelling) / AQWA (Quality)
- MBR validation, OQ and support UAT execution
- Screening of SAP interfaces, support system integration testing
- Create all necessary protocols/ scripts for the execution of identified tests.
- Providing on the job training to the Key users on MBR creations, master data configuration and associated technical aspects
- Support the Site Business users in PQ / UAT in productive environments
- Support to the Local Disaster Recovery test if it is required as part of the project activities
- Responsible for documentation deliverables as per the required customer standards
Montash - SAP - MBR - Designer - SAP - Montash