Leads end-to-end MES deployments for life sciences manufacturing, including requirements engineering, software design, implementation, testing, validation, commissioning, and customer support. Provides technical decision-making, investigates tool issues, supports cGMP and 21 CFR Part 11 compliance, mentors junior engineers, and ensures uninterrupted shop-floor operations. Requires extensive MES project experience, SAP integration knowledge, SQL Server expertise, API and web technology knowledge, and familiarity with formulation manufacturing processes.
Responsibilities
- The role is required to demonstrate thought leadership in software development and Lean/Agile program execution.
- Determine system/product improvement
- MES Project End to End Deployment with validation support to customers
- Requirement Engineering for MES applications
- Determine system/product improvement
- The candidate should have the capability to understand the system requirements and perform full SW life cycle activities (design, implementation, and testing)
- Provide investigation support for tool issues. Handles issues/roadblocks. Participates in design reviews and technical decision making.
- Mentor the junior members in the team and be a problem solver.
- Excellent focus on execution should ensure responsiveness to customers, team.
- Bachelor’s Degree (or equivalent)
- Good Knowledge on Agile based development and deployment.
- Life Science Domain Knowledge (Firm understanding of cGMP validation requirement / guidelines and current industry practice)
- In an agile environment, you implement projects on time and within budget, and you design, develop, install, and commission industrial IT/OT solutions including after-market support.
- ERP Knowledge on Production, Inventory and Warehouse
- 10 to 15 years’ experience in MES applications
- At least 5 end to end MES project implementation experience
- Good communication and articulation skills
- SAP MM / PP / QM / WM modules knowledge related to MES integration
- Design and simulate Master Batch Records
- Ownership of site MES system and provide support to the users for having uninterrupted operations at shop floor using MES
- Liaise between internal teams and external project teams and ensure task completion
- Understanding of 21CFR Part11 requirements for computerized systems and Computer system validation concepts.
- Understand end to end production process of Formulation Manufacturing
- Provide functional guidance to users working on the application
- Experience in SQL Server administration
- Experience in SQL Queries / Views / Stored Procedures
- Knowledge of using JIRA for SDLC
- Knowledge of HTML, JAVA Script, XML, XSLT, WSDL, JSON
- Knowledge of SOAP UI, Post Man, JMeter
- Knowledge on REST API’s, SOAP Web Services
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Leads software development and Agile execution for MES applications, including end-to-end deployment, requirements engineering, design, implementation, testing, validation, customer support, and system improvement. Supports industrial IT/OT solutions, production processes, integrations, and troubleshooting. Provides technical decision-making, issue resolution, user guidance, and mentorship while coordinating internal and external teams. Requires extensive MES implementation experience, pharmaceutical manufacturing knowledge, SAP integration expertise, SQL administration, web technologies, and API testing experience.
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