Type : Contract
Location : Algete, Community of Madrid, Spain-2/3 days a week onsite
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
Your Profile
Essential skills/knowledge/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