MES Validation Engineer - Avispa Technology

MES Validation Engineer ROCGJP00027838

A leading biotechnology company is looking for a Subject Matter Expertise (SME) in the area of validation supporting recipe authoring and system setup/configuration to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO 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.

MES Validation Engineer Pay and Benefits:

• Hourly pay: $80-$90/hr (Pay varies based on the candidate's experience)
• Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment

MES Validation Engineer Specialist Responsibilities:

• Develop proficiency for our standard implementation of the PharmaSuite platform to enable system setup of all master data (materials, equipment, units of measure, security, etc.).
• 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).
• Develop prototypes of recipes and common recipe functionalities (material scans, consumptions, data element tracking to support a recipe execution, calculations, external system communication, etc.) 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 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 our company, 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 (e.g. deployment of printers, HMIs).