MES Recipe Author

Role/

Job Title:

MES Recipe Author

Work Location:

Newbridge, Ireland Mode of Working:
Office based Any other working conditions (travel/on call/shifts):
Travel to sites in Ireland based on requirement

The Role MES Recipe Author for pharmaceutical manufacturing processes (Solid oral dose and packaging preferred) Your responsibilities: (Up to 10, Avoid repetition) 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 Your Profile Essential skills/knowledge/experience: (Up to 10, Avoid repetition) 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 Provide Hyper Care and Go-live support

Experience:

9 Years If you want, I can also create a standard submission format template