EBR Designer

GSK•Marietta, PA

29d

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.