Lead I - Engineering Design

About the role

Based in India, this role will work closely with Greenville Operations, Manufacturing Science and Technology (MSAT), Quality, IT, and MES delivery teams to ensure electronic manufacturing workflows are validated, fit for intended use, and ready for GMP production.

What you'll do

• Own and execute day-to-day CSV deliverables for configured PharmaSuite workflows, with particular emphasis on electronic batch records (eBR)
• Translate manufacturing requirements into risk-based validation evidence, manage test execution and deviations
• Develop and maintain risk-based validation deliverables for Rockwell PharmaSuite MES workflows, including validation plans, requirements and specification traceability
• Review user requirements, process flows, and configured MES recipes/workflows to ensure testing reflects Greenville manufacturing processes and GMP requirements
• Coordinate remote validation execution with site subject-matter experts, MES configuration teams, IT, and Quality; document objective evidence, defects

What you need

• 5–7 years in software engineering
• Change management
• GMP
• Regression testing
• B.Tech or B.E. or B.Sc or BCA

What you get