Validation Engineer - MindSource
Hillsboro, OR 97124
About the Job
Job Title: Validation Engineer
Location: Hillsboro, OR (Onsite)
Duration: 4 months contract with possible of extension
Description:
Looking for 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 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.
Time Period
The overall project duration is TO BE ADJUSTED.
Progress towards these above 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 standard implementation of the PharmaSuite platform to enable better understanding for how to validate a multi-environment implementation, and some 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 (e.g. OPC)
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, 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).
Location: Hillsboro, OR (Onsite)
Duration: 4 months contract with possible of extension
Description:
Looking for 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 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.
Time Period
The overall project duration is TO BE ADJUSTED.
Progress towards these above 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 standard implementation of the PharmaSuite platform to enable better understanding for how to validate a multi-environment implementation, and some 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 (e.g. OPC)
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, 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).
Source : MindSource
