Job Description

Purpose

Tuas is setting up a project team to implement Manufacturing Execution System (MES), to enable the use of electronic batch records (EBR) for the prodcution processes. The EBR Designer posseses good knowledge of production processes and production operations on site and the relevant data flow between systems (i.e. Delta V, OSIPI, MES, SAP).

He / she is required to develop and convert these process and operational requirements from a batch manufacturing sequence in a systematic manner into modular Process Instructions (PI) that are put together in an EBR. He / she is responsible for design, build, test and validate the Master Electronic Batch Records using available global PIs or build new PIs meeting the process or operations user requirements.

MES Specialist (MBR) is a key resource to sustain the EBR lifecycle during routine production after the project phase, and for the site to deploy EBR to products outside the scope of the EBR project

Key Responsibilities

Work with Global MES Team, vendor, SAP SMEs to design, build, test and validate the Master EBRs using available global modules / components, global PIs or build new PIs meeting the process or operations user requirements, and project schedule.

Interact with users (Production and MSAT) to accurately capture the user requirements for designing the Master EBRs and PIs.

MES master data management

Author design and test documentation

Propose recommendations and work with Process User to design of modular PIs and sequencing of PIs into EBR, if the particular module or section of the batch record is not familiar with the EBR designer.

Propose recommendations to MES LBO, Global MES team to design new PIs if existing PIs do not fulfil required functions.

Propose recommendations for issues resolution that requires support, guidance or steering with Project Lead and / or Project Sponsor.

Why you?

Basic Qualifications:

Bachelor\xe2\x80\x99s degree in engineering / Diploma in Engineering

4 to 6 years\' experience in Pharmaceutical Manufacturing

Prior experience with MES usage or MES implementation project is an added advantage.

Knowledgeable in site production and processes and representing them in a flow chart.

Good knowledge of SAP processes in use on site

Knowledgeable in ISA S95 and ISA S88

Knowledgeable in industrial computer systems connectivity and communication protocols requirements in the OTN environment

Knowledgeable in Computer System Validation

Knowledgeable in GMP requirements of Data Management and Control; Electronic Records and Electronic Signatures

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 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. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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GlaxoSmithKline