MES Recipe Author

The Role

·       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

·       Provide HyperCare and Go-live support

·       Experience: 9+ Years