GlaxoSmithKline
EBR Designer
GlaxoSmithKline, Phila, Pennsylvania, United States,
Site Name:
USA - Pennsylvania - MariettaPosted Date:
Jul 11 2024Are you looking for an opportunity to
apply and further develop your digital and leadership skills
while working in a
vibrant, dynamic, and fun environment , and contribute to the
growth and success of our site ? If so, this could be the job for you!As EBR Designer, you will be responsible for the development, creation, update, and testing of electronic batch records in the Siemens OpCenter platform. 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.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.Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:B.S or B.A in Engineering, Computer Science, or other technical degree.Minimum of 3 years' manufacturing industry experience.Preferred Qualifications:
If you have the following characteristics, it would be a plus:Experience in the pharmaceutical industry.Experience in executing projects, testing, and validation in GMP environment.Experience in manufacturing operations.Experience in designing and creating electronic batch records in MES or similar.Experience in technical writing (e.g. validation documents, incident reports).Ability to create process maps for new and existing business processes.Ability to understand process knowledge, elicit and gather user requirements from stakeholders, and translate into business solutions.Proficient in MS Office applications, especially Visio & Excel.Working knowledge of production processes in GMP environment.Base level coding experience with tools like VB Script, MatLab, DaX or similar programming tool (desirable).Base level understanding of databases (desirable).Customer focused, organized, and detail oriented.Must be able to operate independently in a high complex matrix environment. Deliverable oriented; values outcome over output.
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USA - Pennsylvania - MariettaPosted Date:
Jul 11 2024Are you looking for an opportunity to
apply and further develop your digital and leadership skills
while working in a
vibrant, dynamic, and fun environment , and contribute to the
growth and success of our site ? If so, this could be the job for you!As EBR Designer, you will be responsible for the development, creation, update, and testing of electronic batch records in the Siemens OpCenter platform. 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.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.Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:B.S or B.A in Engineering, Computer Science, or other technical degree.Minimum of 3 years' manufacturing industry experience.Preferred Qualifications:
If you have the following characteristics, it would be a plus:Experience in the pharmaceutical industry.Experience in executing projects, testing, and validation in GMP environment.Experience in manufacturing operations.Experience in designing and creating electronic batch records in MES or similar.Experience in technical writing (e.g. validation documents, incident reports).Ability to create process maps for new and existing business processes.Ability to understand process knowledge, elicit and gather user requirements from stakeholders, and translate into business solutions.Proficient in MS Office applications, especially Visio & Excel.Working knowledge of production processes in GMP environment.Base level coding experience with tools like VB Script, MatLab, DaX or similar programming tool (desirable).Base level understanding of databases (desirable).Customer focused, organized, and detail oriented.Must be able to operate independently in a high complex matrix environment. Deliverable oriented; values outcome over output.
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