EBR Designer

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

The purpose of the role is to be primarily responsible for the development, creation, update, and testing of electronic batch records in the Siemens OpCenter platform within the agreed timeline. The role participates, within a multidisciplinary project team, in the analysis and digitalization of new or existing business processes and is responsible for eliciting and gathering user requirements from the production team and converting them into an executable electronic batch record. The role is also responsible for testing, training, and documentation associated with creation and revision of the electronic batch record.

Responsibilities

• Engage process owners and stakeholders to acquire all relevant process information to allow eBR design.
• Design and create/update business process documentation for the electronic Batch Records (eBR) to support MES implementations and eBR lifecycle.
• Convert business process documentation into eBR in MES.
• Create appropriate testing and validation documentation to ensure functional and user requirements are met.
• Test and validate the eBR and associated protocols to ensure it is aligned with existing manufacturing processes
• With support from Tech and Automation, connect eBR to external systems such as OSI-PI and SAP to pull data into eBR.
• Provide support and training to end-users on the use of eBR, troubleshooting eBR issues, and support exception management (e.g. data correction in eBR).
• Drive continuous improvement of the eBR by utilizing data captured in MES, performing Gemba Walks on the shopfloor, and identifying and sharing best practices within and across sites.
• Create documentation to support LSOP creation and training materials.
• Compile and maintain relevant SAP and MES master data
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, industry practice and Industrial Excellence initiatives.