Validation Specialist

3 weeks ago

Hillsboro OR, United States Genentech Full time

The Position

Genentech Inc. seeks 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 at HTO. This will enable reduced cost of ownership by the company, and harmonization of business processes between all sites that use the platform.

A project must be executed as the site transitions from one MES platform to another due to the Syncade platform not aligning with the DP network standard.

The overall project duration is expected to be 36 months.

Pay rate is $110/hr to $130/hr, depending on experience.

This is an on-site position, Monday-Friday, 8:00 to 4:30.

Progress towards milestones will be checked at an agreed upon frequency and billed at that interval based on the work performed to ensure their realization.

Scope of Activities:

  • Develop proficiency for 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.
  • Start development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
  • Create, as directed by Genentech, 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 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).

Qualifications / 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 is required.
  • 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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