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Validation Specialist

2 months ago

Hillsboro, United States Planet Pharma Full time
Job Description

Planet Pharma is seeking a highly skilled Validation Specialist to join our team.

Scope of Activities:

  • Develop proficiency in the standard implementation of the PharmaSuite platform to enable better understanding of how to validate a multi-environment implementation, and provide 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.
  • Develop 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, formal design specifications of system master data configuration.
  • Create project-specific documentation required for implementation, as directed by the company.
  • 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 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).

Requirements:

  • Proficiency in PharmaSuite platform implementation.
  • Experience with 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.
  • Understanding of Core practices for recipe requirement documentation, validation, and project deliverables.
  • Ability to develop recipe and workflow requirement specifications, formal design specifications of system master data configuration.
  • Strong documentation skills.
  • Excellent communication and collaboration skills.