Engineer - MES System

Eli Lilly and Company • Indianapolis, IN

26d • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Engineer MES– Manufacturing and Quality Help us advance our purpose to make life-saving medicines that matter Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site’s and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. The Tech at Lilly MQ team at the Indianapolis Parenteral Manufacturing site is actively looking for a System Engineer for Manufacturing Execution Systems (MES) to focus on Digital Transformation. Are you passionate about manufacturing excellence and applying technology to make reliable and life-saving medicines? If so, bring YOUR skills and talents to Lilly where you’ll have the chance to create an impact on the lives of patients with “Safety First and Quality Always”. What You’ll Be Doing: As an MES System Engineer, you’ll work in a growing organization to help design and develop new electronic Master Batch Records (MBRs) using our Next Generation Manufacturing Execution System (NG MES) Pharmasuite. This role will partner with cross-functional subject matter experts, working to understand the manufacturing process and translate them into system requirements. You will take these requirements and use them to design and build the electronic MBRs. In addition to the designing and developing of the electronic MBRs, you will also help with their validation, deployment, and subsequent support. This project has high visibility and directly impacts our capacity to make medicine for our patients across the globe. This role will tackle business problems and improve business processes by identifying and ensuring the most appropriate solutions are deployed. This role will have a critical part in the digital transformation for Indy Parenteral developing and implementing new capabilities to the site while continuing to enhance and apply existing capabilities.

Requirements

• Experience with designing and developing IT architecture (integrated process, applications, data and technology) and solutions to business problems in alignment with the enterprise architecture direction and standards.
• Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance.
• Experience with identifying system requirements, such as performance, scalability, security, compatibility, interoperability, stability, usability, data integrity and ensure that these requirements are met within the overall system architecture.
• Experience with providing technical guidance to other members of the organization, including developers, project managers, and technical support staff.
• Staying up to date with industry trends and emerging technologies to ensure that the organization's systems remain innovative and effective.
• Superb communication and people skills to build relationships with team members and articulate sophisticated technical concepts.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and lead multiple tasks simultaneously.
• Demonstrable experience in platform practices and procedures such as infrastructure qualification, patching, monitoring, log analysis, edge computing, site reliability engineering, or disaster recovery.
• Consistent track record in tools / platforms such as MES (PMX, PharmaSuite, and/or Syncade) as well as WES/SAP, along with integration technologies enabling data flow with downstream and upstream systems (e.g. SAP, LIMS, MQTT, PI, Data Lakes, Process Monitoring systems such as JMP, Tableau, Power BI)
• Bachelors degree in IT, Science, Technology, Engineering, or related field
• Minimum 1-3 years of IT experience, software engineering, and/or digital capabilities, specifically experience working with Pharmaceutical Manufacturing Execution Systems, specifically PMX, PharmaSuite, and/or Syncade as well as WES/SAP
• Professional experience supporting/developing IT applications/solutions.
• Industry experience.

Nice To Haves

• Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g. cGMP’s, FDA 21 CFR Part 11) and other applicable regulations (e.g. privacy, OSHA, etc.)
• Knowledge of manufacturing operations, Manufacturing Execution Systems (MES) experience, or Pharmaceutical Industry experience.
• Professional experience working in a GXP, regulated environment.

Responsibilities

• Bring your deep technical knowledge and experience to design and develop product architecture for MES and Digital Execution solutions.
• Provide technical support and troubleshooting for manufacturing systems, including MES, automation, and IT infrastructure.
• Diagnose and resolve issues related to equipment, software, and network connectivity to minimize production downtime.
• Collaborate with cross-functional teams, including engineering, operations, and quality, to identify root causes and implement corrective actions.
• Must ensure the compatibility, integration, interoperability, stability, scalability and usability of products/services proposed as standards to ensure an integrated architecture across interdependent technologies.
• Must serve as a technical expert on solutions design, development, and implementation requirements to address business needs.
• Must consider security, privacy and data integrity risks and design IT systems that are secure and protect company data and ensure compliance.
• Possess the capability to communicate sophisticated technical information to both technical and non-technical partners and influence decision making at senior leadership level.
• Develop an in-depth understanding of the business processes at IPM.
• Apply knowledge to assigned solutions to support the operational workflow.
• Work with Process Engineers, Operations, Quality, and Scientists to resolve any issues reported on the solutions implemented.
• Drive the site adoption of assigned solutions, ensuring consistency with Site and IT strategy, and using awareness of internal and external trends in collaboration with the Business SMEs.
• Collaborate with developers and subject authorities (global and local) to establish the technical vision and analyze trade-offs between usability and performance needs.
• Review and approve documentation related to areas of responsibility (Validation Lifecycle documents, SOPs, policies, implemented IQPQ protocols, etc.) as appropriate.
• Develop or update project plans including the determination of project activities and achievements.
• Provided oversight of multiple project and communications status.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees