Lilly
Healthcare
MESEngineer
Neural analysis suggests this role is
optimal for Mid candidates.
“MES Engineer at Lilly. Skills: MES configuration, GxP compliance, Computer System Validation, Pharmaceutical manufacturing. Serve as MES area lead. Configure MES workflows”
What You'll Achieve.
Ensure compliance with 21 CFR Part 11; Ensure compliance with GAMP 5; Ensure compliance with Lilly CSV/CSA standards; Ensure all MES configurations and data flows adhere to data integrity principles; Ensure all MES configurations and data flows adhere to 21 CFR Part 11; Ensure all MES configurations and data flows adhere to Lilly cybersecurity requirements; Keep deliverables on track
Industry & Context.
Analytical and problem-solving skills; Troubleshoot MES configuration issues; Triage defects during testing; Support root cause analysis; Analytical and problem-solving mindset; Work through ambiguity
Hands-on technical practitioner, Functional lead for a manufacturing modality area, SaaS-based MES implementation, Greenfield startup environment, Adapt quickly
What They're Looking For.
Must Have
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field, Minimum of 5+ years of experience working with pharmaceutical manufacturing systems or MES platforms, Minimum of 2+ years experience supporting or leading Computer System Validation (CSV) activities in a GMP-regulated environment, Experience working within or alongside a pharmaceutical manufacturing operation is required
Nice to Have
Hands-on experience configuring and deploying MES platforms in a pharmaceutical GMP environment, ideally including recipe management, eBR authoring, and electronic workflow design, Experience leading or co-leading a functional workstream within a larger IT or MES implementation project, Working knowledge of MES integration concepts, including how MES platforms connect with automation systems, ERP, LIMS, and data infrastructure in a pharmaceutical manufacturing context
What You'll Do.
Serve as MES area lead
Configure MES workflows
Author validation documents
Review validation documents
Coordinate with MES vendor
Facilitate user acceptance testing
Support end-user training
Support go-live readiness
How You'll Work.
Team & Collaboration
Drive alignment across engineering, operations, and quality stakeholders; Partner with process engineers, operations, and quality; Collaborate with process engineering and operations; Work with broader implementation team; Communicate with technical colleagues; Communicate with non-technical manufacturing; Coordinate with broader MES project team; Build effective working relationships across manufacturing, engineering, quality, and IT functions
Communication Scope
Communicate status, risks, and issues clearly and timely; Communicate effectively with technical and non-technical colleagues; Translate MES capabilities and constraints; Excellent communication and collaboration ability
Process & Methodology
Lead modality area through all phases of MES implementation lifecycle, Lead or co-lead a functional workstream, Coordinate tasks, Issue tracking, Stakeholder reporting, Manage multiple concurrent tasks
Full Job Description
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. **Lilly’s Purpose** 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 35,000 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. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. **_What You’ll Be Doing:_** As an MES Engineer at the Lilly Medicine Foundry, you will serve as both a hands-on technical practitioner and the functional lead for a manufacturing modality area for a SaaS-based MES implementation. This role sits at the intersection of systems configuration, GxP compliance, and operational collaboration requiring someone who can drive alignment across engineering, operation
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