Manufacturing Engineer

Role Summary

Manufacturing Engineer at Elanco, focused on implementing and supporting Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES) to bridge digital systems with physical manufacturing processes, ensuring efficient, compliant, and reliable operations.

Responsibilities

• System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of MES/LES solutions. This includes building and modifying electronic batch records (EBRs), system workflows, and configuring equipment integration based on defined requirements.
• Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. Use MES/LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level.
• System Management and Support: Provide frontline technical support for MES and LES platforms. Act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for manufacturing and lab teams.
• Integration: Assist with the integration between MES/LES and other critical systems, such as ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data.
• Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for MES/LES enhancements and new implementations. Generate validation documentation and ensure systems are maintained in a validated state, compliant with GxP and data integrity requirements.
• Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.
• User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the MES/LES systems effectively in their day-to-day roles.

Qualifications

• Educational Background: A Bachelor's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
• Required Experience: 3+ years hands-on experience with the configuration, and support of an MES or LES platform (e.g., Werum PAS-X, Emerson Syncade, POMSnet).
• Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.
• Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.
• Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate 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, with the ability to systematically diagnose and resolve technical issues.
• Process Analysis: Understanding of business process analysis and workflow design; ability to read and interpret process maps and requirements documents.
• Cross-Functional Collaboration: Strong communication and interpersonal skills; ability to work effectively with operators, scientists, and management.
• Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP).
• DevSecOps: Familiarity with CI/CD and source control (Git) concepts is desirable.
• Communication Skills: Strong verbal and written communication skills for collaboration within a technical team.

Education

• Bachelor's degree in Engineering or related technical field.

Additional Requirements

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