Role Summary
The MES Platform Engineer role combines hands-on technical responsibility with end-to-end delivery ownership, spanning system validation, platform configuration, and the introduction of new MES capabilities such as environment builds and Electronic Batch Records. The successful candidate will work as part of a cross-functional team while retaining autonomy to manage and progress their own activities independently.
The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
Role will involve:
Configure and build out MES Platform environments (Dev/Test/Production) in line with project and validation lifecycle requirement.
Provide technical input into MES Platform architecture and configuration decisions during project implementation
Manage the Computer System Validation (CSV) aspect of MES Platform projects from requirements definition to business release
Liaise with service providers and both local and global IT & Quality teams to ensure correct software installation and configuration
Own server installation and system-related activities, e.g. security configuration, admin settings, access permissions
Support integration design and testing between the MES Platform and adjacent systems (e.g. DeltaV, ERP, LIMS)
Generate computer system validation documentation in accordance with site procedures and GMP guidelines
Review and execute test scripts, analyze test results, and determine acceptability of results against pre-determined criteria
Work with the business to identify and implement procedural controls to mitigate issues found during testing
Initiate and implement Change Control activities in accordance with Quality Standards and Practices and Data Integrity standards.
Determine solutions or recommendations for changes and/or improvements
Prioritize validation and platform build activities in line with the project schedule
Collaborating with Global IT and Quality teams
Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.
Key Requirements:
Bachelor’s degree in engineering, Computer Science, or related field with 5+ years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces within a regulated environment.
Hands on experience of MES solutions (preferably Emerson Syncade) including system configuration.
Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
Knowledge of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines beneficial
Experience of electronic testing tools such as ALM and Kneat
Experience of server and workstation platforms and working in a Win 11 environment
Experience in EBR recipe testing and MES deployment
Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
Self-motivated, detail-oriented, and excellent organizational and time management skills Capable of relating well to other people with whom s/he comes in contact
Over Cognizant
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.
Aanvullende arbeidsinformatie
De informatie over de beloning is correct op de datum van deze vacature. Cognizant behoudt zich het recht voor om deze informatie op elk moment te wijzigen, met inachtneming van de toepasselijke wetgeving.
Van sollicitanten kan worden verwacht dat zij gesprekken bijwonen, persoonlijk of via een videogesprek. Daarnaast kan van kandidaten worden gevraagd om tijdens elk gesprek een geldig, door de overheid uitgegeven identiteitsbewijs (zoals een identiteitskaart of paspoort) te tonen.
Cognizant is een werkgever die gelijke kansen biedt. Je sollicitatie en kandidatuur worden niet beoordeeld op basis van ras, huidskleur, geslacht, religie, levensovertuiging, seksuele geaardheid, genderidentiteit, nationale afkomst, handicap, genetische informatie, zwangerschap, veteranenstatus of enige andere eigenschap die wordt beschermd door federale, regionale of lokale wetgeving.
