Pharmasuite Business Integrator M&Q

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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.

Help us advance our purpose to make life-saving medicines that matter

Organization Overview:

At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located, in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.

Lilly's Purpose

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.

What You'll Be Doing:

You will work as a business integrator in a growing organization to help design and develop new electronic tickets using our Next Generation Manufacturing Execution System (NG MES) Pharmasuite. The creation of these electronic tickets will play a pivotal role in helping the local site establish manufacturing capabilities in a new, state-of-the-art plant. This role will partner with cross-functional subject matter experts, working to understand the manufacturing process and translate them into system requirements. You will take these requirements and use them to design and build the electronic tickets while optimizing processes, reducing errors, and increasing efficiency. In addition to the designing and developing of the electronic tickets, you will also help with their validation, deployment, and subsequent support. This project has high visibility and directly impacts our capacity to make medicine for our patients across the globe. This role will tackle business problems and improve business processes by identifying and ensuring the most appropriate solutions are deployed. This role will have a critical part in the digital transformation for Indy Parenteral developing and implementing new capabilities to the site while continuing to enhance and apply existing capabilities.

How You'll Succeed:

• You will engage with other functions to develop a strong understanding of the manufacturing process.
• With a high level of curiosity, you will lead and understand business requirements and bring business process subject matter expertise to build electronic tickets.
• Collaborate with resources, locally and globally, to share learnings, best practices, and identify potential improvement areas
• Contribute to design, development or update of electronic execution tickets and ensure they remain in a validated state during their lifecycle
• You will interface with manufacturing site process and flow teams, leadership, global MQ functional teams, and the broader community at a project, application, or program level.
• You will be responsible for helping with business cases to bring on new services or change existing services while also negotiating clear service levels to meet business availability expectations.
• Jointly with cross-functional teams, you will contribute to or coordinate the development of technical solutions.
• You will support the definition and gathering of requirements.
• You will ensure appropriate business roles are engaged in solution execution.
• You will support client acceptance testing.
• You will be responsible for building quality and data integrity into solutions through awareness and knowledge of regulatory, legal, or quality requirements impacting the business area.
• Through curiosity and initiative, stay abreast of latest technology standards and trends.
• You will conduct benchmarking internally and externally, if required.

What You Should Bring:

• Experience with MES technologies and their delivery in a regulated environment
• Solid knowledge of Computer System Validation process
• Demonstrated learning agility and curiosity
• Demonstrated ability to influence without authority
• Strong problem-solving skills, analytical, & process improvement skills
• Excellent communication and interpersonal skills to build relationships and articulate complex technical concepts.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Basic understanding of Good Manufacturing Practices (cGMP) with demonstrated experience in computer system validations efforts.
• Demonstrated curiosity for continuous learning
• Customer and team oriented.
• Experience leading project implementations
• Organization skills and self-motivated
• Additional Experience in the following would be preferred but not required:
  • Understanding of cybersecurity concepts and best practices related to application and platforms operating within a S95 Architecture.
  • SQL databases,
  • Microsoft Windows Servers
  • Recipe Authoring
  • ERP, LIMS, or other manufacturing systems interfacing design, development, and/or support.

Basic Qualifications:

• Bachelors in IT, Science, Technology Engineering, or related field.
• Minimum 1-3 years of IT experience, software engineering, and/or digital capabilities
• Pharmasuite Manufacturing Execution System (MES) experience

Additional Information:

• Position based in Indianapolis, Indiana
• 8-hour days, possible after-hour support
• On site presence minimum 4 days a week
• Occasional travel may be required.
• Must maintain a safe work environment, working safely and accountable for supporting all health and safety corporate and site goals.
• Professional experience supporting/developing IT applications/solutions
• Knowledge of manufacturing operations and/or Pharmaceutical Industry experience.
• Professional experience working in a GXP, regulated environment

About the Organization

Lilly IT builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Lilly IT is that we create new possibilities through tech to advance our purpose - creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business.

The Manufacturing and Quality Tech team leverages technology and analytics to transform and scale manufacturing to the digital plant of the future and support manufacturing operational excellence and productivity. This team helps produce medicines using machine learning and robotic capabilities with some of the most sophisticated manufacturing technologies and rigorous quality standards.

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 ( ) 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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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