Validation Engineer

6 days ago


Hillsboro, United States The Fountain Group Full time

Pay Range: $60-100+/hr depending on experience

Contract: 6 months with possible extension and/or conversion

100% onsite


Job Description:

  • Needs a 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 as it would enable 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.
  • Develop proficiency for the company standard implementation of the PharmaSuite platform to enable better understanding for 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). Start development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
  • Creation and finalizing recipe requirement specifications for all recipes and workflows to be converted into PharmaSuite.


Qualifications:

  • Computer System Validation (CSV) experience
  • Automation / DeltaV / or MES experience preferred

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