MES Recipe Author

Job Title: MES Recipe Author

Job Type: Contract

Location: Kalamazoo, MI /Remote

Job summary

• Experience in implementation of MES- PharmaSuite (5 yrs). Candidate can be trained in PharmaSuite, however, they must have PAS-X and Syncade experience as these products are similar to PharmaSuite.
• The candidate needs to have at least 5-6 years of experience designing EBRs.
• Sharing a brief writeup from HM about the role below.
• Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents.
• Gather MES Site specific requirement analysis to develop URS and FRS.
• Logically breakdown the recipes/Mfg. process to configure recipes.
• Develop/create MBR design elements (building blocks) and e-logbook workflows for repetitive use in MBR creation to expedite the process.
• Gather master data and configure in MES Development/Quality/Production Environment.
• Integrating MES with SAP and other automation systems using standard interface component of MBR design.
• Lead the recipe design session with business process SMEs.
• Design MBR/recipe, equipment workflow/ status diagram based on the Business process flow.
• Create solution design and configuration document.
• Prepare key user training documents and impart key user training.
• Provide assistance in business SOP creation.
• The candidate needs to have at least 5-6 years of experience designing EBRs on PharmaSuite MES
• The person will be responsible for prototyping and designing EBRs
• Process involves buffer prep, solution prep, Vaccine Manufacturing and packaging
• JD:
• Design, preparation and revision of Electronic Batch Records (EBR), where applicable, through established change control processes.
• Having thorough knowledge of manufacturing execution system (MES), recipe design, baseline configuration, create and execute functional verification protocols.
• Support end users on EBR execution and usage.
• Manage EBR design and configuration changes, process reviews and alignment with associated documentation used to the continuity plan.
• Initiating change controls and ensuring their closure and implementation of changes.
• Participate in process mapping of business processes.
• Support continuous improvement and batch record changes as applicable.
• Participate in cross functional teams to support, enhance, and upgrade of MES system.
• Technical document writing for procedures, specifications and functional verification protocols creation and execution.

VDart Inc is the leading global provider of digital solutions, products and talent management company providing digital technology solutions in Automotive, Manufacturing, Energy & Utilities and Healthcare Industries. Led by a strong global team located across 10 countries including USA, Canada, Mexico, Brazil, UK, Japan, Australia & India. We are currently accepting applications from staffing firms for our Preferred Partner Program, where we align niche staffing firms with specific verticals based on their strengths.