Recipe Author

MES Recipe Author for pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
Your responsibilities:

Execution and coordination of responsibilities that include Master Recipe creation, master data creation, maintenance and control of MES activities (Recipe and workflow designer, PMC, PEC, PRC and Data manager Clients).

Process mapping (visio), Recipe designing, Testing, Dry runs and Business verification of the created recipes.

Understanding of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)

Possesses expertise in Good Documentation and Good Testing Practices

Building, Testing and verifying of recipes which require Integration (SAP, gLIMS, catalyst etc).

Coordination with core and site teams for new site-specific requirements.

Ability to work with site SMEs to turn paper batch records into EBRs in Rockwell Pharmasuite utilizing existing functionality

Ability to work with site SMEs to turn existing EBRs in legacy systems (P2C2, PMX, etc.) into Rockwell Pharmasuite EBRs utilizing existing functionality

Ability to design Building Blocks that can be reused in multiple processes

Ability to work in a fact paced agile team environment

Preparing and conducting UAT, Change management, Validation Documentation, User training

Essential skills/knowledge/experience:

Must Have – Rockwell PharmaSuite Recipe Author experience

Expert in PharmaSuite and specific functionalities.

Participates in fit gap analysis & Process Modeling & process standardization with Area lead & Process SME

Works with lead RA to develop BB requirements

Provide times, user story point estimates, and status for all stories assigned to them

Authors and performs documents supporting validation of EBRs

Configures EBR in Development, Stage, & Production Environment

Address Site specific questions, use cases and ER from Site EBR and PO

Works across the teams to put requirement together for ER development

#J-18808-Ljbffr