Sr. Principal Architect - MES/Digital Execution System

Eli Lilly and Company; Lebanon (IN); On-site; USD 80,000 - 140,000; Full time

Job summary

An established industry player is seeking a Senior Technical Architect to lead the implementation of Manufacturing Execution Systems (MES) at their new facility. This role will focus on crafting IT architecture solutions that address complex business challenges in the pharmaceutical manufacturing domain. You will be at the forefront of deploying innovative technologies and ensuring seamless integration with existing systems. Join a dynamic team dedicated to delivering life-changing medicines and improving supply chain strength. This is a unique opportunity to make a significant impact in a growing organization that values innovation and operational excellence.

Benefits

Potential to work after hours

On-site work 4 days a week

Qualifications

• 3+ years experience with Pharmaceutical MES and API manufacturing.
• Deep expertise in IT architecture and data integrity compliance.

Responsibilities

• Lead implementation of MES for paperless execution in manufacturing.
• Develop robust IT architecture solutions for business challenges.

Skills

IT architecture design

Pharmaceutical Manufacturing Execution Systems (MES)

Data Integrity compliance

Communication skills

Adaptability

Technical guidance

Integration technologies

Python

SQL

Cloud architecture

Education

Bachelor’s degree in Software Engineering

Bachelor’s degree in Computer Science

Bachelor’s degree in Computer Engineering

Tools

MES Syncade

PharmaSuite

Pas-X

SAP

Tableau

Power BI

Git

JSON

YAML

REST

Job 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 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.

This is an opportunity you don’t want to miss!

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly research tech has a growing need for in-house manufacturing of material for clinical supplies and will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API). This new facility will meet the needs for a rapidly growing portfolio (more and new areas), to accelerate development timelines, and to improve supply chain strength. The brand-new facility, also known as Lilly Medicine Foundry (LMF) will utilize the latest technology to augment the current clinical supply chain for small molecules (SM), oligonucleotides, peptides, and Antibody Drug Conjugates (ADCs), monoclonal antibodies and bioconjugates, and add new capabilities including mRNA. This new site will be built using the latest high-tech equipment, sophisticated highly coordinated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

What You’ll Be Doing:

As the Senior Technical Architect for Manufacturing Execution Systems (MES), your main responsibility will be to craft and develop robust IT architecture solutions tailored to sophisticated business challenges within the pharmaceutical manufacturing domain. This role demands a deep technical expertise in creating integrated process, application, data, and technology architectures, ensuring conformity with enterprise standards and strategic goals.

At the Lilly Medicine Foundry (LMF), you will lead the implementation of complex MES, driving the transition to paperless execution from the facility's inception. Your role will involve deploying innovative technologies, ensuring seamless integration with existing systems, and collaborating multi-functionally to uphold the Manufacturing Strategy for Operational Excellence. You will be instrumental in delivering IT solutions that meet exacting quality standards and facilitate the site’s mission and vision.

How You Will Succeed:

• Bring your deep technical knowledge and experience to design and develop product architecture for MES and Digital Execution solutions.
• Must ensure the compatibility, integration, interoperability, stability, scalability and usability of products/services proposed as standards to ensure an integrated architecture across interdependent technologies.
• Must serve as a technical expert on solutions design, development, and implementation requirements to address business needs.
• Must consider security, privacy and data integrity risks and design IT systems that are secure and protect company data and ensure compliance.
• Possess the capability to communicate sophisticated technical information to both technical and non-technical partners and influence decision making at senior leadership level.
• Develop an in-depth understanding of the business processes at LMF. Apply knowledge to assigned solutions to support the operational workflow. Work with Process Engineers, Operations, Quality, and Scientists to resolve any issues reported on the solutions implemented.
• Drive the site adoption of assigned solutions, ensuring consistency with Site and IT strategy, and using awareness of internal and external trends in collaboration with the Business SMEs.
• Collaborate with developers and subject authorities (global and local) to establish the technical vision and analyze trade-offs between usability and performance needs.
• Review and approve documentation related to areas of responsibility (Validation Lifecycle documents, SOPs, policies, implemented IQPQ protocols, etc.) as appropriate.

What You Should Bring

• Experience with designing and developing IT architecture (integrated process, applications, data and technology) and solutions to business problems in alignment with the enterprise architecture direction and standards.
• Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance.
• Experience with identifying system requirements, such as performance, scalability, security, compatibility, interoperability, stability, usability, data integrity and ensure that these requirements are met within the overall system architecture.
• Experience with providing technical guidance to other members of the organization, including developers, project managers, and technical support staff.
• Staying up to date with industry trends and emerging technologies to ensure that the organization's systems remain innovative and effective.
• Superb communication and people skills to build relationships with team members and articulate sophisticated technical concepts.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and lead multiple tasks simultaneously.
• Extensive background with MES and how to integrate with Automation, Lab and other Local/Global IT platforms.
• Consistent track record in tools / platforms such as MES Syncade, PharmaSuite, Pas-X, Tulip or similar and Integration technologies enabling data flow with downstream and upstream systems (e.g. SAP, LIMS, DeltaV, MQTT, UNS, Aveva PI, Data Lakes, Process Monitoring systems such as JMP, Tableau, Power BI or similar)
• Demonstrable experience in platform practices and procedures such as infrastructure qualification, patching, monitoring, log analysis, edge computing, site reliability engineering, or disaster recovery.
• Demonstrable experience in languages, tools and concepts such as Python, JSON, YAML, SQL, or Git, Github, C#, SQL, XML, REST, OPCUA, Data Modeling, Web Development, Cloud first architecture
• Develop or update project plans including the determination of project activities and achievements. Provided oversight of multiple project and communications status.

Your Basic Qualifications:

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
• Minimum of 3+ years of experience working with Pharmaceutical Manufacturing Execution Systems (e.g. Data solutions, MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X).
• Minimum of 3+years of experience on API manufacturing facilities.

Additional Information:

• This position will be on site 4 days a week
• Potential to work after hours

This position will initially start in Indianapolis but will be transferred to the Foundry in Lebanon, IN!