Principal Architect - MES
BioSpace
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Benefits offered by this job
Job summary
Qualifications
- 6+ years of experience working with Pharmaceutical Manufacturing Execution Systems.
- Experience in designing and developing IT architecture solutions.
- Familiarity with industry regulations for Computer Systems Validation.
Responsibilities
- Craft and develop robust IT architecture solutions for MES.
- Collaborate with cross-functional teams to address business needs.
- Ensure compliance with security and data integrity standards.
Skills
Education
Tools
Job description
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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.
Sr. Principal Architect - MES
This is an opportunity you don’t want to miss!
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. 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.
The Tech@Lilly MQ team at the Indianapolis Parenteral Manufacturing site is actively looking for a Senior Architect for Manufacturing Execution Systems (MES). Are you passionate about manufacturing excellence and applying technology to make reliable and life-saving medicines? Are you wanting to work in to work in a diverse and inclusive, fast-paced and dynamic environment? If so, bring YOUR skills and talents to Lilly where you’ll have the chance to create an impact on the lives of patients with “Safety First and Quality Always”.
What You’ll Be Doing
As the Senior MES Architect, 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 Indy Parenteral Manufacturing (IPM) you will help lead the implementation of complex MES, driving the transition from PMX to PharmaSuite. Your role will involve deploying innovative technologies, while ensuring sustainability and robustness of existing manufacturing and warehouse systems, as well as 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.
- Provide technical support and troubleshooting for manufacturing systems, including MES, automation, and IT infrastructure.
- Diagnose and resolve issues related to equipment, software, and network connectivity to minimize production downtime.
- Collaborate with cross-functional teams, including engineering, operations, and quality, to identify root causes and implement corrective actions.
- 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 IPM. 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.
- 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.
- Demonstrable experience in platform practices and procedures such as infrastructure qualification, patching, monitoring, log analysis, edge computing, site reliability engineering, or disaster recovery.
- Consistent track record in tools / platforms such as MES (PMX, PharmaSuite, and/or Syncade) as well as WES/SAP, along with integration technologies enabling data flow with downstream and upstream systems (e.g. SAP, LIMS, MQTT, PI, Data Lakes, Process Monitoring systems such as JMP, Tableau, Power BI)
- Develop or update project plans including the determination of project activities and achievements. Provided oversight of multiple project and communications status.
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
- Minimum of 6+ years of experience working with Pharmaceutical Manufacturing Execution Systems, specifically PMX, PharmaSuite, and/or Syncade as well as WES/SAP.
- Minimum of 6+years of experience on pharmaceutical manufacturing facilities
- Extensive background with MES and how to integrate with Warehouse, Automation, Lab and other Local/Global IT platforms.
- Technology experience including Windows OS, Linux OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, ServiceNow.
- Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g. cGMP’s, FDA 21 CFR Part 11) and other applicable regulations (e.g. privacy, OSHA, etc.).
- This position will be on site 4 days a week
- Potential travel and after-hours work
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $180,400
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.
#WeAreLilly
- Seniority levelMid-Senior level
- Employment typeFull-time
- Job functionDesign, Art/Creative, and Information Technology
- IndustriesInternet News
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