MES Werum PAS-X Designers

MES Werum PASX Designers

To centrally develop a standard set of Generic Master Batch Record (GMBR's) to be deployed globally.

Design batch records from the bottom up: starting with the compliance expectations, add process direction and variation and enable MES functionality.

Enable productivity improvements due to implementation of Review by Exception (RbE)/auto closure by elimination full record revie and routing for approval.

Support the client with maximizing the use of GMBR's to allow for MBRs parameterised based on site and process needs.

Decrease expectations by elimination of Manual entries, match record design to execution needs and simpler record design.

The resource to work with customer to deliver the business process GMBRs, documentation, labelling requirements design guidelines and integration standards.

MBR development tasks:

Define Unit operation inputs, outputs and variations required.

Gather input from Amgen process owners, Automation team, Process Development Team, MES Platform Representative.

Develop the GMBR

Collaborate with the integration team and automation system stakeholders to ensure alignment between the MBR and automated systems.

Conduct design review and process level health check with the site representatives and stakeholders.

Qualify the GMBR using customer electronic validation system.

Oversee Amgen MBR approval process owners and secure approval from the process owner and peer author and quality.

Integration development standards consists of:

Gathering inputs from MBR authors, process owners and MES platform Representative to determine MBR requirements of data required from automation systems.

Review and assess automation systems for data availability and escalate gaps to site automation and development teams.

Develop documentation for integration touchpoints for each MBR

Review and assess