Description
Project Goal:
Seeking a FTPS Recipe Author to support pharmaceutical manufacturing processes, focusing on electronic batch records (EBRs) implementation using Rockwell Pharmasuite.
Main Tasks:
• Conduct fit gap analysis and process modeling with Area lead & Process SME
• Develop Building Block requirements with lead RA
• Configure EBRs in Development, Stage, and Production environments
• Author and perform validation documentation for EBRs
• Process map site requirements using Microsoft Visio or similar software
• Convert paper batch records and legacy system EBRs (P2C2, PMX) to Rockwell Pharmasuite
• Provide time estimates, story points, and status updates for assigned tasks
• Address site-specific questions and use cases
• Provide HyperCare and Go-live support
Required Skills:
• Knowledge of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
• Expertise in Good Documentation and Good Testing Practices
• Proficiency in Microsoft Visio or similar software
• Experience with Rockwell Pharmasuite
• Ability to design reusable Building Blocks
• Experience in authoring requirements, SPEC, and validation documents
• EBR testing capabilities in compliance with regulations
• Strong teamwork skills in fast-paced agile environments
Work Model:
• Remote work with required travel to Ascoli, Italy when needed
Seeking a FTPS Recipe Author to support pharmaceutical manufacturing processes, focusing on electronic batch records (EBRs) implementation using Rockwell Pharmasuite.
Main Tasks:
• Conduct fit gap analysis and process modeling with Area lead & Process SME
• Develop Building Block requirements with lead RA
• Configure EBRs in Development, Stage, and Production environments
• Author and perform validation documentation for EBRs
• Process map site requirements using Microsoft Visio or similar software
• Convert paper batch records and legacy system EBRs (P2C2, PMX) to Rockwell Pharmasuite
• Provide time estimates, story points, and status updates for assigned tasks
• Address site-specific questions and use cases
• Provide HyperCare and Go-live support
Required Skills:
• Knowledge of pharmaceutical manufacturing processes (Solid oral dose and packaging preferred)
• Expertise in Good Documentation and Good Testing Practices
• Proficiency in Microsoft Visio or similar software
• Experience with Rockwell Pharmasuite
• Ability to design reusable Building Blocks
• Experience in authoring requirements, SPEC, and validation documents
• EBR testing capabilities in compliance with regulations
• Strong teamwork skills in fast-paced agile environments
Work Model:
• Remote work with required travel to Ascoli, Italy when needed