Dublin  

About SimoTech

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
 

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
 

MES Systems Lead 1562

SimoTech is seeking an MES Systems Lead to deliver a major Werum PAS-X MES implementation at a global pharmaceutical fill-finish facility in Dublin. Acting as the MES SME and Technical Lead on this capital project, you’ll drive system design, configuration, and integration, ensuring full compliance and operational alignment.
 
This is a key role focused on driving increased production at the site, through close collaboration with business process owners, manufacturing, and QA teams, as well as integration with SAP systems. The ideal candidate will bring 8+ years of PAS-X experience, deep expertise with MBR/EBR development, and a strong background in GMP drug product manufacturing.

Key Responsibilities

• Act as the Subject Mater Expert for the Manufacturing Execution System (MES) on behalf of Client.
• Serve as Technical Lead for the MES scope, ensuring high-quality system design, configuration, and coding standards throughout the project lifecycle.
• Work with the core MES team to implement instances of MES for the Drug Product facility.
• Direct system integrators and internal teams to ensure MES deliverables align with the project scope and standards.
• Gather and communicate business requirements, leading design workshops to translate them into functional specifications.
• Collaborate closely with Process Owners and manufacturing stakeholders to design workflows, instructions, and electronic records.
• Review and approve all design deliverables to ensure alignment with business and operational objectives.
• Plan, oversee, and support User Acceptance Testing (UAT).
• Work closely with Process Owners, the Design team and all stakeholders to ensure successful project delivery.
• Ensure that the MES system meets business requirements and delivers operational functionality.
• Oversee change control processes and uphold high standards of documentation and traceability across the project lifecycle.
• Work closely with CSV, QA, and commissioning teams to ensure compliance, support commissioning and qualification activities, and deliver a smooth handover to operations.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or similar with hands-on experience in GMP-regulated Drug Production Fill Finish environment.
• 8+ years’ experience with Werum PAS-X MES technology, experience with version 3.3 is a distinct advantage.
• Strong expertise in architecture design, server planning and setup, and system configuration and administration.
• Proven experience in Master Batch Record (MBR) development, Electronic Batch Records (EBR), and Recipe Parameter configuration.
• Experience in Level 2 integration and interfacing MES with SAP systems.
• Demonstrated leadership capabilities, with a track record of successfully delivering on MES capital projects.
• Excellent interpersonal and communication skills.

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
• Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
• Opportunity to work with large corporate clients on exciting capital projects.

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