MSD MES Technical Lead 

Ireland, Dublin 

819116803

Job Description

A fantastic opportunity has arisen for anMES Technical Lead.

• The MES Technical Lead - Manufacturing Execution System MES Senior Specialist for the design, management, and continuous improvement of our site Electronic Batch Records processes.
• As part of the Manufacturing Division network, the Biotech Dublin team will manufacture, test and release critical biologics products used globally in lifesaving medicines. To support excellence in production execution, this biologics drug substance facility (BDS) will be supported by a local, small MES Team made up of technical experts that are responsible for leading the management and improvement of MES across the site.
• Our Company utilises Werum PAS-X software application as its corporate standard for MES. On site there is a high degree of integration between MES and other systems including SAP (release ofManufacturing/ProcessOrders, Material tracking) and RTMS (Finite scheduling and Capacity analysis).
• The MES Technical Lead will provide site support for continuous improvement changes, fixes, updates and further deployment of the site Manufacturing Execution System and processes to enabling the team to produce critical biologics medicines at the highest standards of quality and compliance.

What you will do:

Bring energy, knowledge and innovation to carry out the following:

• Lead initiatives to ensure the site MES supports Manufacturing execution and timely Batch Disposition and provides for a continuous improvement environment.
• Engage with the Our Company’s MES CoE (Centre of Excellence) to ensure our Company’s templates, libraries, and best practice configurations from the of our Company’s Network are applied where applicable.
• Resolution of technical and configuration issues. Lead the investigation and troubleshooting of issues and development and implementation of corrective and preventative actions.
• Ensure issues and risks that cannot be addressed by the site team are escalated and actioned appropriately with above site support groups and/or external vendors.
• Lead Operations and Tech Operations in developing a sustainable MBR update model. Work with team to develop a prioritized list of changes.
• Assess complexity of proposed Master Batch Record changes for Dispensary, Upstream and Downstream processes.
• Manage various workflows to support the process of MES Updates, including Change definition with MBR Owners, creation of required change controls, and execution of user acceptance test (UAT) protocols.
• Once change scope has been defined, develop a schedule for delivery of the updates.
• Update MBR design and associated design documentation with new changes.
• Assess opportunities for enhanced use of MES and related technology to drive performance and compliance improvements in Manufacturing and Disposition.
• Develop plan for implementation of new system improvements across site Master Batch Records (MBRs), Equipment Specification Protocols/Records (ESPs) and Parameter Value Lists (PVLs).
• Plan, agree and implement communications strategy to keep stakeholders informed regarding site MES program.
• Align with the COMET (SAP) and Scheduling (RTMS) teams on future strategies and further integration of the digital systems.
• Author and approve SOPs and other required system user / administrator instruction / documentation.
• Devise, agree and implement user training plan, based around existing Our Company’s MES training content.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A minimum of 10 years relevant industry experience.
• In-depth knowledge of PAS-X, or other Electronic Batch Record software required.
• Demonstrated successes in a team environment.
• Experience in a highly regulated GMP Manufacturing Environment in a technical or manufacturing support role.
• Demonstrated problem solving capabilities.
• Start-up experience in a large-scale commercial drug substance facility desirable.
• Knowledge and expertise of MES principles related to and expertise with typical biopharmaceutical upstream and downstream processing and support equipment.
• Experience in a Vaccines, Biologics or Sterile pharmaceutical manufacturing environment.
• Experience with operations start-up activity including greenfield or brownfield facilities.
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with above site MES Centre of Excellence in a team orientated manner.
• Excellent analytical and systematic problem-solving skills
• Ability to interact with multiple stakeholders across numerous departments.
• Ability to work independently and as part of a team.
• Lead the MES effort with a team to achieve multiple target conditions to achieve an overall challenge.
• Strong influencing skills.
• Bachelor’s Degree in Science, Engineering or related field

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.