Senior MES Platform Engineer - Hybrid, Validation & EBRs

SimoTech; Cork; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Autonomy to drive initiatives

Skills development with innovativeTech

Exposure to large corporate clients

Job summary

SimoTech is seeking an experienced MES Platform Engineer to support a global pharmaceutical client in a hybrid role. You will maintain and evolve a critical MES landscape, handle server installations, and drive validation activities across the lifecycle.

The role requires hands-on MES configuration, 21 CFR Part 11 knowledge, and collaboration with IT, Quality, and external service providers. Join a high-performing team and contribute to compliance and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field with 5+ years’ experience in IT systems implementation, integration, computer systems validation, and support within a regulated environment.
• Strong hands-on experience with MES platforms, preferably Emerson Syncade, including system configuration.
• Proven experience across the full validation lifecycle, including requirements gathering, design documentation, testing, and troubleshooting.
• Solid understanding of 21 CFR Part 11, electronic records and signatures, and data integrity guidelines.
• Experience using validation and testing tools such as Kneat and ALM.
• Working knowledge of server, workstation, and Windows-based environments.
• Experience in EBR testing and MES deployment activities preferred.
• Strong communication and interpersonal skills, with the ability to engage effectively across technical and business teams.

Responsibilities

• Maintain and evolve a MES landscape within a high-performing manufacturing environment.
• Take responsibility for server installations and system related activities including admin config settings, security, and access permissions.
• Collaborate with local and global IT, Quality, and external service providers to ensure successful software installation and configuration.
• Manage the Computer System Validation lifecycle for MES projects, from requirements definition through to business release.
• Generate CSV documentation in line with site procedures, GMP guidelines, and data integrity standards.
• Execute and review test scripts, analyse results, and ensure compliance with pre-defined acceptance criteria.
• Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
• Determine solutions and provide recommendations for changes and improvements.
• Prioritise validation activities in line with the project schedule.
• Ensure adherence to all Environmental, Health and Safety requirements and contribute to incident investigations where required.

Skills

MES platform experience

Emerson Syncade

Validation lifecycle

GMP compliance

Kneat

ALM

Windows environments

EBR testing

Education

Bachelor's degree in Engineering, Computer Science, or related field

Tools

Kneat

ALM

Emerson Syncade

Job description

SimoTech is seeking an experienced MES Platform Engineer to support a global pharmaceutical client in a hybrid role. You will maintain and evolve a critical MES landscape, handle server installations, and drive validation activities across the lifecycle.

The role requires hands-on MES configuration, 21 CFR Part 11 knowledge, and collaboration with IT, Quality, and external service providers. Join a high-performing team and contribute to compliance and continuous improvement.