MES Engineer (Contractor)

Genentech Inc. needs Subject Matter Expertise (SME) in the area of 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.

The overall project duration is 3 / 31 / 25 (possible extension up to 36 months)

Pay rate $130 / hr to $151 / hr (depends on experience)

On-site position, Monday-Friday, 8 : 00 to 4 : 30

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 Roche 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 Genentech, 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).

Qualifications / Requirements :

• BS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
• A minimum of 2 years of manufacturing execution systems (MES) experience is required
• Proficient in Pharma Suite required

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