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

• Must Have – Rockwell Pharma Suite Recipe Author experience
• Expert in Pharma Suite 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 E  in Development, Stage, & Production Environment
• Address Site specific questions, use cases and ER from Site E  and PO
• Works across the teams to put requirement together for ER development