MES Platform Engineer

Cognizant Technology Solutions Corporation; Cork; On-site; EUR 70,000 - 95,000; Full time

Job summary

Cognizant Technology Solutions Corporation in Cork, Ireland is seeking an MES Platform Engineer to own end-to-end delivery of MES environments and validation within a regulated API manufacturing setting.

You will configure Dev/Test/Production environments, contribute to platform architecture and CSV validation, and liaise with local and global IT and Quality teams to ensure compliant installation and configuration.

Qualifications

• Bachelor’s degree in engineering, CS, or related field.
• 5+ years implementing IT solutions in regulated environments.
• Hands-on MES experience, preferably with Emerson Syncade.
• Experience writing validation plans and system documentation.
• Knowledge of 21CFR Part 11, data integrity guidelines.
• Experience with electronic testing tools (ALM, Kneat).
• Experience with server/workstation platforms in Windows 11.
• Experience in EBR testing and MES deployment.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Configure and build MES environments (Dev/Test/Prod) per validation lifecycle.
• Contribute to MES platform architecture and configuration decisions.
• Manage CSV validation from requirements to business release.
• Coordinate with IT & Quality teams for software installation and config.
• Oversee server installation, security config, access control.
• Support integration testing with DeltaV, ERP, LIMS.
• Create and review validation documentation per GMP/site procedures.
• Prioritize validation activities to align with project schedule.
• Support Change Control activities and data integrity standards.
• Collaborate with Global IT and Quality teams.

Skills

MES platform

CSV validation

Regulated environment

Emerson Syncade

System configuration

Validation plans

21 CFR Part 11

ALM

Kneat

DeltaV

LIMS

ERP

Education

Bachelor’s degree in engineering or computer science

Tools

Emerson Syncade

ALM

Kneat

DeltaV

LIMS

ERP

Job description

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