Description
Manufacturing Execution Systems Documentation and Project Change Control Support required for an initial 12 month contract on site at a pharmaceutical company in Dublin.The MES Support is responsible for developing and maintaining appropriate MES content and changes to meet the facility goals of High Product Quality and Lean Manufacturing.
Role and responsibilities:
- The role will work under the direction of the MES Recipe Author Lead (MES-SRAL). Works closely with other team members from the corporate Paperless Plant Initiative (PPI) team to deliver the MES master recipes.
- Performs MES activities to ensure appropriate MES content/development and changes to meet the facility goals of High Product Quality and Lean Manufacturing.
- Actively participates in the creation of project deliverables such as design documents, configuration, installation and validation activities as required by the MES delivery project manager.
- Gathers input and coordinates with project team to develop project change control requirements.
- Participates in the testing and computer system validation of the MES Recipes and related configuration as required by the MES delivery project manager.
- Participates in the validation script creation and testing required for each MES recipe to meet site business requirements and specifications.
- Assures all design & project work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP's), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
- Supports the project manager on any documentation development and configuration activity as needed.
- Contribute to a high-performance culture by recognising and resolving issues as they arise.