Manufacturing Engineer

Role Summary

Manufacturing Engineer at Elanco, focusing on implementing and supporting Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES). Acts as the bridge between physical manufacturing processes and digital systems to ensure efficient, compliant, and reliable operations.

Responsibilities

• System Design and Configuration: Contribute to design and be responsible for configuring and implementing MES/LES solutions, including building/modifying electronic batch records (EBRs), system workflows, and equipment integration based on requirements.
• Process Optimization: Analyze manufacturing and laboratory workflows with operations and quality teams; use MES/LES capabilities to implement process improvements, reduce cycle times, and enhance data integrity at the shop-floor level.
• System Management and Support: Provide frontline technical support for MES and LES platforms; troubleshoot and resolve system issues to ensure high availability for manufacturing and lab teams.
• Integration: Assist with integrating MES/LES with other systems (ERP SAP, LIMS, PLCs/SCADA) to ensure reliable data flow.
• Validation and Compliance: Execute IQ/OQ/PQ validation for MES/LES enhancements and new implementations; generate validation documentation and maintain systems in a validated state compliant with GxP and data integrity.
• Stakeholder Collaboration: Work with Manufacturing Operations, Quality Assurance, and Process Science teams to gather requirements and provide updates on technical activities.
• User Training and Enablement: Develop training materials and conduct sessions to ensure personnel are proficient in using MES/LES systems in day-to-day roles.

Qualifications

• Educational Background: Bachelor's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or related technical field.
• Required Experience: 3+ years configuring and supporting an MES or LES platform (e.g., Werum PAS-X, Emerson Syncade, POMSnet).
• Manufacturing Environment Experience: Experience in a manufacturing environment, preferably in pharmaceutical, biologics, animal health, or another GxP-regulated industry.
• Regulatory Knowledge: Working knowledge of GxP and familiarity with computer system validation (CSV) principles.
• Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and integration with higher-level manufacturing systems.
• Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation.

Skills

• Problem-Solving: Strong analytical and troubleshooting skills; ability to diagnose and resolve technical issues.
• Process Analysis: Understanding of business process analysis and workflow design; ability to read/process maps and requirements documents.
• Cross-Functional Collaboration: Effective communication and interpersonal skills; ability to work with operators, scientists, and management.
• Cloud Platform Proficiency: Familiarity with Microsoft Azure or Google Cloud Platform (GCP) is a plus.
• DevSecOps: Familiarity with CI/CD and source control (Git) is desirable.
• Communication: Strong verbal and written communication within a technical team.

Education

• Relevant Bachelor's degree as listed in Qualifications.

Additional Requirements

• Location: Global Headquarters - Indianapolis, IN (Hybrid environment)
• Travel: Minimal