Overview
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 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 put people first and seek individuals determined to make life better for people around the world.
At Lilly in Germany, we are planning and building a high-tech production facility in Alzey (Rhineland-Palatinate) to expand our production of injectable drugs from 2027, employing up to 1,000 specialists. We seek motivated individuals to join us and help ensure the supply of Lilly medicines in Germany, Europe, and worldwide, aligned with Lilly values of Excellence, Integrity, and Respect for People.
Responsibilities
* Lead the successful implementation of the MES solution across the organization.
* Leverage deep MES knowledge, collaborate with cross-functional and global teams, and design tailored solutions to optimize manufacturing processes, enhance compliance and efficiency, and drive site-level operational excellence.
Key Objectives/Deliverables
* Data/Information Vision and Strategy: work with the business to identify future uses for Lilly data and anticipated business results, enabling processes to support these needs.
* Take ownership of the end-to-end MES implementation process, including requirements gathering, solution design, configuration, testing, deployment, and ongoing support.
* Collaborate with stakeholders to analyze business needs, define functional requirements, and design MES solutions that align with goals and industry best practices.
* Develop and execute project plans with timelines, resource allocation, and risk mitigation to meet budget and schedule constraints.
* Build relationships with senior management, department leaders, and end-users to understand requirements, gain buy-in, and ensure adoption of the MES system.
* Work with global IT, operations, automation, engineering, technical services and quality teams to integrate the MES solution with existing systems and processes, ensuring data integrity, reliability, and scalability.
* Configure and customize the MES system to meet specific business needs for a tailored solution that maximizes efficiency.
* Develop training programs and materials for end-users; create documentation including user guides, SOPs, and technical specifications.
* Stay informed on industry trends, emerging technologies, and best practices related to MES implementation; identify opportunities for process improvements and system enhancements.
* Lead ongoing support, troubleshooting, and maintenance of the MES system to ensure high availability and performance.
* Translate complex concepts into understandable terms for diverse audiences and bridge gaps between technical and business requirements.
* Define and lead governance of the MES agenda, including stakeholder communications, prioritization, scorecards, and program promotion to the global organization and site employees.
* Represent Alzey in global MES forums to provide visibility of local needs and concerns.
* Ensure MES compliance with industry regulations (FDA guidelines, GMP, Lilly policies) and local procedures to maintain product quality and safety.
* Develop and execute comprehensive testing strategies (unit, system integration, and user acceptance testing) to validate functionality, performance, and reliability.
* MES System Custodian responsibilities include compliant and reliable operation, data integrity, configuration management, validation support, and driving GMP-aligned continuous improvement.
* Collaborate with internal and external auditors to facilitate MES audits and inspections and address findings promptly.
Basic Qualifications
* Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
* Minimum of 7+ years of MES implementation experience in a GMP-regulated industry.
* Experience with IT audits, compliance assessments, and remediation activities, including addressing findings and implementing corrective actions.
* Deep knowledge and experience with MES platforms (e.g., Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, Werum PAS-X).
* Familiarity with ISA-95, OPC, and data historians.
* Experience leading end-to-end MES implementation projects in GMP environments, from requirements to deployment, with resource, timeline, and risk management.
* Proficiency in project management methodologies (Agile or Waterfall).
* Experience integrating MES with ERP and SCADA for seamless data flow and interoperability.
* Knowledge of data management principles, including validation, transformation, migration, and reporting.
* Strong understanding of pharmaceutical manufacturing processes and GMP regulatory requirements (e.g., FDA).
* Change management skills to drive adoption of MES systems and processes.
* Excellent communication and interpersonal skills for engagement with stakeholders at all levels.
* Strong analytical and problem-solving skills for MES configurations and integrations.
* Ability to troubleshoot performance, data integrity, or connectivity issues with IT and vendor collaboration.
* Proven leadership to manage cross-functional teams and drive high-quality deliverables.
* Experience mentoring team members and promoting growth.
* Understanding of cybersecurity concepts related to MES technologies.
* Adaptability to work in a fast-paced environment and manage multiple tasks.
Additional Skills/Preferences
* Master’s degree in Computer Science, Information Technology, Business Administration, or related field is preferred.
* Experience with international operations, diverse teams, and global IT projects.
* Proficiency in German and strong English skills.
* On-site presence required.
What you can look forward to with us
* Pioneering spirit: Become part of a team that will grow to up to 1,000 colleagues over the next three years.
* Innovation: Work in a medical high-tech production facility with advanced technology.
* Creative freedom: Contribute ideas and implement them in cross-functional teams from day one.
* Development: Lilly supports individual career development worldwide through Lilly University.
* Financial benefits: Competitive salary with an excellent company pension plan and other benefits.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities for applicants. If you require accommodation to submit a resume, please complete the accommodation request form at the following URL: https://careers.lilly.com/us/en/workplace-accommodation. 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 other legally protected status.
#WeAreLilly
#J-18808-Ljbffr