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.
What You’ll Be Doing:
You will be part of Tech at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.
As a MES system engineer within the IT organization that supports the Alcobendas packaging site, you will play a critical role in designing, supporting and developing Manufacturing Execution System (MES) electronic batch records and logbooks, associated tools, and system interfaces to fulfil business needs; deploys existing systems, analyses information, designs, programs and/or implements new systems or enhancements to existing systems in accordance with company standards and guidelines.
How You’ll Succeed:
Implement, configure, and support the MES platform for packaging operations at Alcobendas.
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) 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, according to Good Manufacturing Practices.
Develop and maintain system documentation, SOPs, training materials, and support guides tailored to Alcobendas 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 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, automation systems, or SAP EWM).
Willingness to learn and grow technical skills as the MES platform and site capabilities evolve.
Ability to work in a fast-paced, global, and regulated environment, with a focus on operational excellence.
Basic Requirements:
Bachelor’s degree in IT, computer science, computer engineering or related field.
2+ years MES experience (PharmaSuite or PMX are preferred).
2+ years experience with MES system design, implementation, and validation.
Additional Preferences:
Experience in regulated pharmaceutical or medical device manufacturing environments.
Familiarity with MES platforms such as PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV or similar.
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.
Infrastructure knowledge or experience will be taken in account positively.
Other Information:
Role is based onsite at Alcobendas site.
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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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