EBR Designer

About this role

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 This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • 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.

Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Bachelor’s degree in engineering, computer science, information systems, or related technical discipline, or equivalent experience. • 3+ years’ experience working in a manufacturing environment. • 2+ years’ experience with MES design, eBR development, or similar digital manufacturing tools. • Experience creating process documentation, flowcharts, or Visio diagrams. • Experience with testing and validation in a regulated environment. • Hands-on experience with Siemens OpCenter or another MES platform.

Preferred Qualification If you have the following characteristics, it would be a plus: • Experience in pharmaceutical or biotech manufacturing.. • Familiarity with integration technologies (OSI-PI, SAP, APIs) and basic scripting or coding. • Experience with GMP documentation, validation protocols, and compliance activities. • Customer-focused, organized, and able to work independently in a matrix environment. • Strong written and verbal communication skills and ability to work with cross-functional teams.

#LI-GSK

Skills Business Analysis, Business Requirements Analysis, Data Validation, Decision Making, Project Scoping, Stakeholder Management    

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -  usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis pr

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