IDAP MES System Engineer Tech at Lilly
BioSpace - Indianapolis, IN
Hiring: IDAP MES System Engineer Tech at Lilly Company: BioSpace Location: Indianapolis, IN Job Posted Time: 2026-09-10 10:24:03 Employment Type: Full-time Target Skills & Keywords : Assembly, Systems Design About the job Experience: •2+ years experience with MES system design, implementation, and validation. •3+ years of experience in regulated pharmaceutical or medical device manufacturing environments. •2+ years MES experience, and/or at least 1 year in PharmaSuite deployments . •At least 1 year in PharmaSuite deployments . Required Skills: •Work closely with site Operations, Quality, Engineering, and IT teams to translate operational needs into executable MES solutions. This role is ideal for someone who is passionate about technology, systems thinking, and supporting frontline manufacturing teams. •Implementing, configuring, and supporting the MES solution at IDAP, ensuring that it meets the site’s operational, quality, and compliance needs. You will work closely with Operations, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities •Implement, configure, and support the MES platform for device assembly and packaging operations at IDAP. •Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes. •Execute and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness. •Troubleshoot MES issues and collaborate with cross-functional teams to resolve system or process gaps. •Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting. •Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5. Qualifications: •Bachelor’s degree in IT, computer science, computer engineering or related field. •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. •Operational familiarity with MES platforms such as PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred. •Strong communication skills (written and verbal) with the ability to communicate at all levels of the organization. •Proven experience in stakeholder management and cross-functional coordination. •Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). •Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials. •Demonstrated capacity to work cross-functionally and communicate effectively with technical and non-technical stakeholders. Compensation: •$64,500 - $158,400 / year •Flexible work environment (work from home / hybrid options) •Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!