Manufacturing Execution System Electronic Batch Record Designer

Job description

Nombre del sítio: USA - Montana - Hamilton
Fecha de publicación: Feb 2 2024

The Manufacturing Execution System (MES) e lectronic Batch Record (eRB) Designer  will create the Process Instructions (PI’s) for MES and maintain the lifecycle of the system.

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

·  Development, creation, testing and maintenance of electronic batch records and checklists, including associated master data, in the MES Siemens application based on the requirements of the respective production area.
·  Support the creation and maintenance of the necessary documents (specifications, validation forms).
·  Creating/adapting, or supporting the creation/adaptation of Excel-based specifications for the electronic record (electronic Batch Records and checklists) in collaboration with employees from production, automation and QA
·  Creating/configuring electronic Batch Records (eBR’s) and checklists in Siemens application
·  Definition of test scenarios for the validation of the created electronic eBR’s and checklists
·  Execution and documentation of test runs to verify the created electronic eBR’s and checklists
·  Preparation of reports on the processing of the deficiencies that occurred in the course of the test
·  Assist in the preparation of test and validation documentation for the created electronic eBR’s and checklists
·  Support in the preparation of amendments for the adaptation of the electronic eBR’s and checklists; deliver their implementation
·  The perception of the role of a key user for the Siemens application as the first point of contact for questions and challenges in the system application (first level support)
·  Implementation of system and SOP training(s) for new users
·  Other duties as defined in the MES capability matrix

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  High School Diploma/GED and 5+ years of experience in cGMP, FDA and other regulatory environment OR Bachelors Degree and 2+ years in a cGMP, FDA or other regulatory environment

Preferred Qualifications:

·  Experience with MS Office (Word, Excel, Visio)
·  Experience in technical writing (validation documents, defect reports)
·  Experience in carrying out qualifications and/or validation
·  Experience in creating and/or maintaining Manufacturing batch records
·  Ability to logically structure and sequence workflows in a GMP environment
·  Knowledge of the requirements for GMP-compliant documentation
·  Knowledge in the creation of test strategies for computer system validations
·  Understanding of automation technology or experience in this field is preferred
·  Understanding of SAP production master data
·  Ability to work in a team and communicate appropriately
·  Experience in delivering training

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

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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