MES Recipe Author Associate

Overview

Join Lilly's MES deployment team in Hyderabad to author, validate and support MES recipes across manufacturing sites.

What you'll do

• Author, configure, and maintain MES recipes, including Generic Master Batch Records (GMBR) and Production Master Batch Records (PMBR), on PharmaSuite or Werum PAS-X platforms
• Support MES recipes in production, including troubleshooting, making changes, and ensuring recipe integrity during live operations
• Manage recipe migration and promotion across environments (Dev → Test/QA → Validation → Production) following change control processes
• Perform end-to-end recipe validation, including test script authoring, execution, and documentation in line with GxP/CSV requirements
• Collaborate with cross-functional MES deployment engineers to plan and execute recipe releases and site go-lives
• Provide L2/L3 support for recipe-related incidents, performing root cause analysis and implementing corrective/preventive actions
• Ensure all recipe changes comply with data integrity (ALCOA+), 21 CFR Part 11, and Annex 11 requirements
• Partner with Manufacturing, Quality, and Validation teams to align recipe design with process and compliance needs
• Maintain accurate documentation for authored or modified recipes, including change records and test evidence

What you'll need

• 3–5 years of experience in MES recipe authoring and support
• Hands-on experience with PharmaSuite or Werum PAS-X MES platforms
• Practical exposure to GMBR and PMBR authoring and lifecycle management
• Experience moving or deploying recipes across multiple environments
• Working knowledge of recipe/system validation practices (IQ/OQ/PQ, test scripting)
• Experience in a production support role (L2/L3) within a regulated manufacturing environment
• Understanding of GxP, CSV/GAMP 5, and pharmaceutical manufacturing quality processes
• Strong troubleshooting and root-cause analysis skills
• Good communication skills to work with global/cross-site manufacturing and quality teams

Nice to have

• Prior experience working within a global pharmaceutical manufacturing IT/MES deployment team
• Exposure to change control and deviation management processes in a validated environment
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field

Details

• Location: Hyderabad, India