Senior Validation Specialist
4 weeks ago
Job Description:
The client requires a Subject Matter Expert in validation to support recipes and workflows and system setup/configuration for the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. This will enable reduced cost of ownership and harmonization of business processes between all sites using the platform.
As the Syncade platform does not align with the DP network standard, a project must be executed to transition from one MES platform to another.
Key Responsibilities:
- Develop proficiency in the client's standard implementation of the PharmaSuite platform to enable a better understanding of how to validate a multi-environment implementation and support system configuration.
- Develop proficiency in interfaces to the PharmaSuite platform, including warehouse management through the eWM module of SAP, SAP manufacturing, Mulesoft middleware layers, and communication to DeltaV, PI, and other manufacturing automation systems using industry-standard technologies.
- Develop an understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables, etc.
- Create project-specific documentation required for implementation.
- Develop validation test scripts for all system functionality (recipes, workflows, master data).
- Finalize and implement in test, reference, and production environments the final master data configuration.
- Support validation activities, including authoring of test scripts, dry runs, and formal execution, as required to achieve project timelines.
- Plan and implement project cutover solutions and support the cutover of the system including activities occurring in the manufacturing space.
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