Validation Engineer

Title: Sr Validation Engineer, Req#: ROCGJP00027838
Location: Hillsboro, OR (100% onsite)
Duration: 4+ months Contract (with the possibility of extension based on performance)

Job Description:

The client needs Subject Matter Expertise (SME) in the area of validation supporting recipes and workflows and system setup/configuration to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO as it would enable the reduced cost of ownership by the company and harmonization of business processes between all sites that use the platform. As the Syncade platform does not align with the DP network standard, a project must be executed as the site transitions from one MES platform to another.

Scope of Activities:

• Develop proficiency for the the client’s standard implementation of the PharmaSuite platform to enable a better understanding of how to validate a multi-environment implementation and some support for actual 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 (e.g. OPC)
• Develop an understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables such as project and implementation plans, etc.
• Start development of recipe and workflow requirement specifications and formal design specifications of system master data configuration.
• Create, as directed by the client, project-specific documentation required for implementation.
• Creation and finalizing recipe requirement specifications for all recipes and workflows to be converted into PharmaSuite
• Developing validation test scripts for all system functionality (recipes, workflows, master data)
• Finalizing and implementing 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 (e.g. deployment of printers, HMIs).

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