Manufacturing Systems Specialist

11 hours ago


Hillsboro, United States TalentBurst, an Inc 5000 company Full time
Sr Validation Engineer

Req#: ROCGJP

Location: Hillsboro, OR (100% onsite)

Duration: 4+ months Contract (with the possibility of extension based on performance)

Job Description:

The client requires a Subject Matter Expert (SME) 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.

Scope of Activities:

  • 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 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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