Medical Device Embedded System Engineer Jobs in Fishers, IN

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Position Brand 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 38,000 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 individuals who are determined to make life better for people around the world.
As a MES System Engineer supporting the Indianapolis Device Assembly & Packaging (IDAP) site, you will play a critical role in implementing and sustaining our next-generation Manufacturing Execution System (MES). This system is central to our digital transformation strategy, supporting paperless operations, enhancing compliance, and enabling efficient batch execution.
You will 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.
What You'll Be Doing:
You will be responsible for 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
How You'll Succeed:

• 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.
• Develop and maintain system documentation, SOPs, training materials, and support guides tailored to IDAP operations.
• Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.
• Identify opportunities for continuous improvement, error-proofing, and digital optimization at the site.
• Actively engage in site huddles, team discussions, and problem-solving initiatives

What You Should Bring:

• Experience supporting MES in a regulated manufacturing environment, ideally in device assembly or packaging operations.
• Working knowledge of cGMP and Computer System Validation (CSV) frameworks
• Ability to interpret process requirements and translate them into MES configurations or electronic batch records.
• Strong troubleshooting skills, with the ability to investigate system issues, identify root causes, and implement sustainable solutions.
• Comfortable working on the shop floor with operations, quality, and engineering teams to gather feedback and support adoption.
• Excellent collaboration and communication skills able to navigate cross-functional environments and bridge technical and business teams.
• Ability to manage multiple priorities and adapt to changing project needs.
• Proactive mindset with a focus on continuous improvement and system optimization.
• Familiarity with system integration concepts (e.g., MES to ERP or automation systems).
• Willingness to learn and grow technical skills as the MES platform and site capabilities evolve.

Basic Requirements:

• Bachelor's degree in IT, computer science, computer engineering or related field.
• 2+ years experience with MES system design, implementation, and validation.
• 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
• 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.

Additional Preferences:

• 2+ years MES experience, and/or at least 1 year in PharmaSuite deployments .
• Familiarity with MES platforms such as PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred.
• Experience with Microsoft Office Suite (Excel, Word, PowerPoint).
• 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).
• Experience authoring and validating Master Batch Records (MBRs) in a regulated environment.
• Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
• Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.

Other Information:

• Role is based onsite at Lilly Tech Center South (IDAP) site.
• Occasional travel to other Lilly sites or vendor locations may be required 5-10%
• Flexibility for off-hours work supporting manufacturing operations or during implementation windows is expected.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $158,400
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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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