Director Computer System Validation Csv Jobs in Indiana

Job Summary:
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. They are seeking an MES Systems Engineer to support and evolve manufacturing execution systems, ensuring compliance and operational excellence while contributing to digital transformation initiatives.
Responsibilities:
• Design, configure, and support MES and Digital Execution solutions that enable safe, efficient pharmaceutical manufacturing.
• Provide hands‑on technical support for manufacturing systems, including MES, automation, and supporting IT infrastructure, helping to quickly diagnose and resolve issues that impact operations.
• Troubleshoot equipment, software, and network‑related issues to minimize downtime and support reliable production.
• Partner closely with Engineering, Operations, Quality, and IT to investigate issues, identify root causes, and implement sustainable solutions.
• Contribute to the design of integrated, scalable, and user‑friendly MES solutions, ensuring systems work seamlessly across manufacturing and digital platforms.
• Apply technical expertise to translate business and manufacturing needs into practical system designs and configurations.
• Incorporate security, data integrity, and compliance considerations into system designs to protect company data and meet regulatory expectations.
• Communicate technical concepts clearly to both technical and non‑technical stakeholders, supporting informed decision‑making.
• Build a strong understanding of IPM manufacturing processes and use that knowledge to support and improve operational workflows.
• Support adoption of new and existing digital solutions by working with business SMEs and aligning with site and IT strategies.
• Collaborate with global and local technical experts to help shape solution direction and balance usability, performance, and maintainability.
• Participate in the review and approval of validation and lifecycle documentation (e.g., SOPs, protocols, and system records) to support compliant system delivery.
Qualifications:
Required:
• Experience supporting Manufacturing Execution Systems (MES), such as PMX and/or PharmaSuite, with the ability to translate manufacturing needs into system requirements, configurations, and electronic batch record (eMBR) updates.
• Exposure to or interest in supporting MES platform transitions, including learning and contributing to PMX → PharmaSuite migration activities in a phased manufacturing environment.
• Experience in computer system validation (CSV) activities, including test execution and documentation, with an understanding of data integrity expectations in a regulated environment.
• Ability to help gather and document non‑functional requirements (performance, security, usability, data integrity, reliability) and work collaboratively with other MES engineers or architects to implement solutions that meet those needs.
• Hands‑on troubleshooting skills for MES‑related issues, including application behavior, system interfaces, and connectivity, with a collaborative approach to identifying root causes and reducing production downtime.
• Strong collaboration skills and experience working with cross‑functional teams such as Operations, Engineering, Quality, and IT to support adoption and sustained use of digital manufacturing solutions.
• Awareness of secure and compliant system use, including following access, security, and data protection practices in regulated manufacturing systems.
• Exposure to reporting, dashboards, or manufacturing data flows, with the ability to support data continuity as systems modernize.
• Experience supporting project execution through task tracking, status updates, and coordination within a defined workstream or project team.
• Curiosity and a growth mindset, with an interest in learning new technologies and manufacturing digital trends to continuously improve system reliability and execution.
• Clear communication skills, with the ability to explain technical concepts to both technical and non‑technical partners and document work in a concise, understandable way.
• Bachelors in IT, Science, Technology Engineering, or related field.
• 1+ years of IT experience, software engineering, and/or digital capabilities, specifically experience working with Pharmaceutical Manufacturing Execution Systems, specifically PMX, PharmaSuite, PAS-X, and/or Syncade as well as WES/SAP.
• Experience supporting/developing IT applications/solutions.
• Hands-on experience with manufacturing operations and Manufacturing Execution Systems (MES), including implementation, integration, support, or optimization in a manufacturing environment.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Preferred:
• Experience working in a GXP, regulated environment.
• 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.)
Company:
We're a medicine company turning science into healing to make life better for people around the world. Founded in 1876, the company is headquartered in Indianapolis, USA, with a team of 10001+ employees. The company is currently Late Stage.