MES Validation Specialist
3 days ago
A leading biotechnology company is seeking a highly skilled MES Validation Engineer to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The successful candidate will enable reduced cost of ownership by the company and harmonization of business processes between all sites that use the platform.
Key Responsibilities:
- Develop proficiency in the standard implementation of the PharmaSuite platform to enable system setup of all master data.
- 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.
- Develop prototypes of recipes and common recipe functionalities and demonstrate to manufacturing and quality personnel.
- Develop knowledge on batch record structure and exception handling, with sharing among the broader project team and affected site personnel.
- Develop understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables, etc.
- Start development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
- Create project-specific documentation required for implementation.
- Creation and finalizing recipe requirement specifications for all recipes and workflows to be converted into PharmaSuite.
- Finalizing all recipes and workflows to support production activities.
- Finalizing and implementing in validation, reference, and production environments final master data configuration.
- Support validation activities, including reviews 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.
Requirements:
- Hourly pay: $80-$90/hr (Pay varies based on the candidate's experience)
- Worksite: Leading biotechnology company (Hillsboro, OR Onsite)
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
- 40 hours/week, 6 Month Assignment
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