Architect - MES Solution

IIBA (International Institute of Business Analysis); Sesto Fiorentino; Ibrido; EUR 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

A global healthcare leader is seeking a MES Solution Architect to drive the successful implementation of their MES solution. The role involves leading the design and configuration of electronic manufacturing batch records while ensuring compliance with validation requirements. Ideal candidates should have a bachelor's in IT or related field, at least 7 years of experience in life science manufacturing, and be proficient in English.

Competenze

• At least 7 years of experience as an IT Business Integrator or IT Project Leader in Life Science Manufacturing.
• Understanding of GMP regulations and Computer System Validation (CSV) principles.
• Proficiency in English (written and spoken).

Mansioni

• Act as the design lead for Electronic Manufacturing Batch Records.
• Lead the configuration of MBRs for manufacturing processes.
• Collaborate with cross-functional teams for requirements gathering.

Conoscenze

Cross-functional communication

Problem-solving

Project management

Formazione

Bachelor's Degree in IT, Computer Science, Engineering

Strumenti

PharmaSuite

PMX

DeltaV

Descrizione del lavoro

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.

MES Solution Architect

Position Title: MES Solution Architect

Position Type: Full-time

Job Family: Information Technology

Location/s: Indianapolis, Charlotte, Raleigh-Durham, Kenosha, Puerto Rico, Alcobendas, Fegersheim, Alzey, Sesto

Job Function: Tech@Lilly

Tech Ladder (Y/N): Y

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 more than 45,000 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 is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site's and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

Position Brand Description

We are on an ambitious journey to transform our manufacturing operations, and the Manufacturing Execution System (MES) is pivotal to achieving this transformation. Multiple projects are currently underway to expand the footprint of MES, enabling new facilities to operate paperless and modernizing MES in established operations worldwide.

The MES Solution Architect will ensure the successful implementation of the NextGen MES solution by bridging business needs and technology. This role will develop expertise in PharmaSuite, supporting, developing and validating global electronic batch records to fulfill business needs. Working closely with global and site teams, MES Solution Architect will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.

Key Objectives/Deliverables:

• Act as the process-specific design lead for Electronic Manufacturing Batch Records (MBRs), ensuring alignment with both global standards and site-specific requirements.
• Lead the design and configuration of MBRs for a given manufacturing or packaging process, collaborating closely with site teams and global Subject Matter Experts (SMEs).
• Identify synergies across manufacturing sites to drive harmonization and promote reuse of MBR components.
• Define and maintain clear boundaries between Global MBR content and Site-specific localization to ensure standardization and flexibility.
• Ensure that MBR designs reflect compliant, efficient, and scalable manufacturing processes.
• Collaborate with cross-functional teams (Technical Service /Manufacturing Science, Process Engineering, QA, IT) to gather process requirements and translate them into MES functional design.
• Serve as the main point of contact for MBR-related topics during NG MES deployments, from initial scoping to validation.
• Contribute to the creation and governance of Global Design Templates and Configuration Standards for MES.
• Provide guidance and coaching to local teams during MBR design and testing activities.
• Continuously improve the design process by incorporating lessons learned and best practices from prior deployments.

Basic Requirements

• Education: Bachelor's Degree in IT, Computer Science, Engineering, or equivalent years of experience.
• Minimum 7 years as an IT Business Integrator or IT Project Leader in Life Science Manufacturing.
• Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
• Familiarity with MES platforms such as PharmaSuite (preferred), PMX, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred.
• Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.
• Proficiency in English (written and spoken).

Additional Skills/Preferences:

• Experience working globally, influencing without authority, and resolving complex issues.
• Learning agility, subject matter expertise in Life Sciences.
• Knowledge of Business Process development, SOPs, Governance Processes, and Program Management.
• Risk-based decision making, diverse communication methods, and strong account management skills.

Additional Information:

• Position locations: Indianapolis, Charlotte, Raleigh-Durham, Kenosha, Puerto Rico, Alcobendas, Fegersheim, Alzey, Sesto
• Occasional off-hours and weekend work expected.
• 10-15% domestic/international travel required.

Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

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. #WeAreLilly

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.

#WeAreLilly