MES Engineer Specialist

MES Engineer

Role Overview

An experienced MES Engineer is required to join an established Manufacturing Execution Systems (MES) team supporting biotech manufacturing operations at a regulated production site.

The role focuses on the design, development, enhancement, and support of electronic batch records (EBRs) and MES recipes within a GMP environment, with strong involvement in system validation, testing, and documentation. You will work closely with manufacturing, quality, automation, and IT stakeholders to support live operations and deliver system improvements.

Key Responsibilities

• Partner with business and manufacturing stakeholders to gather and translate user requirements into compliant MES solutions.

• Design and develop new electronic batch records and work instructions within the MES platform.

• Modify, enhance, and deploy changes to existing live recipes, ensuring minimal impact to manufacturing.

• Produce and review design specifications, configuration documents, and technical documentation aligned with GMP and CSV expectations.

• Develop, execute, and review test scripts (IQ/OQ/PQ or equivalent) to support system changes and new MES functionality.

• Support computer system validation (CSV) activities in line with regulatory requirements and site procedures.

• Utilise Kneat (or similar validation lifecycle management tools) to manage validation documentation, testing, and traceability.

• Provide day-to-day MES support, including troubleshooting and resolution of system and recipe-related issues.

• Participate in design reviews and risk assessments, ensuring traceability from requirements through to testing and release.

• Apply an object-oriented development approach to create reusable MES objects across multiple batch records.

• Coordinate and participate in solution testing, ensuring robust testing practices and documentation standards are followed.

• Support investigations and resolution of production-impacting MES issues.

• Identify and drive continuous improvement opportunities across MES delivery, validation, and support processes.

• Collaborate with IT, automation, and manufacturing teams to deliver solutions aligned with business and quality needs.

• Stay current with emerging MES technologies, regulatory expectations, and industry best practices.

Required Skills & Experience

• Strong experience with object-oriented programming, including Visual Basic scripting.

• Proven experience implementing and supporting MES solutions in a GMP-regulated environment.

• Demonstrated experience with computer system validation (CSV), including requirements, design specifications, risk assessments, and testing.

• Hands-on experience developing and executing test scripts and supporting validated system releases.

• Experience using Kneat or similar electronic validation lifecycle management systems.

• Strong ability to troubleshoot and support MES or comparable manufacturing systems.

• Experience working within a development team, with the ability to take ownership of issues and solution delivery.

• Direct experience engaging with end users for requirements gathering and translation into technical solutions.

• Good working knowledge of automation systems, historians, and DCS platforms.

• Solid understanding of GMPs, regulatory requirements, and data integrity principles.

• Excellent written and verbal communication skills for both technical and non-technical stakeholders.

• Demonstrated learning agility across both technical systems and manufacturing processes.

• Proactive mindset with the ability to identify issues, implement solutions, or escalate appropriately.

Nice to Have

• Experience supporting biotech or pharmaceutical manufacturing environments

• Exposure to PAS-X, Syncade, or similar MES platforms

• Experience working in live manufacturing environments with frequent system changes

MES Engineer

Role Overview

An experienced MES Engineer is required to join an established Manufacturing Execution Systems (MES) team supporting biotech manufacturing operations at a regulated production site.

The role focuses on the design, development, enhancement, and support of electronic batch records (EBRs) and MES recipes within a GMP environment, with strong involvement in system validation, testing, and documentation. You will work closely with manufacturing, quality, automation, and IT stakeholders to support live operations and deliver system improvements.

Key Responsibilities

• Partner with business and manufacturing stakeholders to gather and translate user requirements into compliant MES solutions.

• Design and develop new electronic batch records and work instructions within the MES platform.

• Modify, enhance, and deploy changes to existing live recipes, ensuring minimal impact to manufacturing.

• Produce and review design specifications, configuration documents, and technical documentation aligned with GMP and CSV expectations.

• Develop, execute, and review test scripts (IQ/OQ/PQ or equivalent) to support system changes and new MES functionality.

• Support computer system validation (CSV) activities in line with regulatory requirements and site procedures.

• Utilise Kneat (or similar validation lifecycle management tools) to manage validation documentation, testing, and traceability.

• Provide day-to-day MES support, including troubleshooting and resolution of system and recipe-related issues.

• Participate in design reviews and risk assessments, ensuring traceability from requirements through to testing and release.

• Apply an object-oriented development approach to create reusable MES objects across multiple batch records.

• Coordinate and participate in solution testing, ensuring robust testing practices and documentation standards are followed.

• Support investigations and resolution of production-impacting MES issues.

• Identify and drive continuous improvement opportunities across MES delivery, validation, and support processes.

• Collaborate with IT, automation, and manufacturing teams to deliver solutions aligned with business and quality needs.

• Stay current with emerging MES technologies, regulatory expectations, and industry best practices.

Required Skills & Experience

• Strong experience with object-oriented programming, including Visual Basic scripting.

• Proven experience implementing and supporting MES solutions in a GMP-regulated environment.

• Demonstrated experience with computer system validation (CSV), including requirements, design specifications, risk assessments, and testing.

• Hands-on experience developing and executing test scripts and supporting validated system releases.

• Experience using Kneat or similar electronic validation lifecycle management systems.

• Strong ability to troubleshoot and support MES or comparable manufacturing systems.

• Experience working within a development team, with the ability to take ownership of issues and solution delivery.

• Direct experience engaging with end users for requirements gathering and translation into technical solutions.

• Good working knowledge of automation systems, historians, and DCS platforms.

• Solid understanding of GMPs, regulatory requirements, and data integrity principles.

• Excellent written and verbal communication skills for both technical and non-technical stakeholders.

• Demonstrated learning agility across both technical systems and manufacturing processes.

• Proactive mindset with the ability to identify issues, implement solutions, or escalate appropriately.

Nice to Have

• Experience supporting biotech or pharmaceutical manufacturing environments

• Exposure to PAS-X, Syncade, or similar MES platforms

• Experience working in live manufacturing environments with frequent system changes