PharmaSuite EBR Specialist | GMP, Validation & Go-Live

Required Skills Strong understanding of pharmaceutical manufacturing processes, especially solid oral dose and packaging Expertise in Good Documentation Practices (GDP) and Good Testing Practices (GTP) Ability to process map site requirements using tools like Microsoft Visio Experience working with site SMEs to convert paper batch records to Electronic Batch Records (EBRs) in Rockwell PharmaSuite using standard functionality Ability to migrate existing EBRs from legacy systems (P2C2, PMX, etc.) into Rockwell PharmaSuite Skilled in designing reusable Building Blocks (BBs) for multiple processes Ability to author requirements, specifications (SPEC), and validation documentation Competency in performing full EBR functional testing in a compliant manner Comfortable working in a fast-paced, agile team environment Roles & Responsibilities Participate in fit-gap analysis, process modeling, and process standardization with area leads and process SMEs Collaborate with lead Requirements Analysts (RAs) to define Building Block requirements Provide time estimates, story point estimates, and status updates for assigned work items Author and execute validation documentation for EBRs Configure EBRs across Development, Stage, and Production environments Address site-specific questions, use cases, and enhancement requests related to EBRs and product ownership Work cross-functionally to gather detailed requirements for enhancement requests (ERs) Provide HyperCare and Go-Live support during deployments #J-18808-Ljbffr Veriipro