Validation Expert

6 days ago


Salem, Oregon, United States Genentech Full time
Job Title: Validation Expert

Genentech Inc. is seeking a highly skilled Validation Expert to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The successful candidate will have expertise in computerized system validation in a GMP environment and proficiency in Pharma Suite.

Key Responsibilities:
  • Develop proficiency in the Roche standard implementation of the PharmaSuite platform to enable better understanding for how to validate a multi-environment implementation.
  • 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.
  • Create, as directed by Genentech, project-specific documentation required for implementation.
  • Support validation activities, including authoring of test scripts, dry runs, and formal execution, as required to achieve project timelines.
Requirements:
  • BS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent, with a minimum of 2 years' experience in computerized system validation in a GMP environment.
  • Proficient in Pharma Suite preferred.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.



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