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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.

Organization Overview

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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility from the ground up as a member of the site IT organization.

The Manufacturing Execution Systems (MES) Systems Engineer is responsible for the deployment and continuous improvement of Manufacturing Execution System (MES) electronic batch records for RTP parenteral operations. This role will pair technical mastery of MES for drug product operations with cross-functional collaboration to expand and operationalize the MES footprint as part of the overall site ramp up, in alignment with RTP business objectives and IT standards.

Key Objectives/Responsibilities

MES Technical Ownership

• Provide technical oversight to development, deployment, and maintenance of MES Electronic Batch Record (EBR) and ancillary electronic tickets to drug product manufacturing lines.
• Collaborate with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality, Operations, Learning & Development, and global counterparts to ensure MES functionality aligns with procedures and training.
• Engage in lifecycle management initiatives to ensure a modern technology footprint aligned with corporate and regulatory policies.
• Advocate for quality improvement practices in EBR design and maintenance.
• Comply with the organization’s safety goals and objectives, and incorporate safety principles into MES design, as applicable.
• Collaborate with MES peers, MES support personnel, and cross-functional MES colleagues consistent with Lilly values, emphasizing knowledge management, technical troubleshooting, accountability, and continuous improvement.
• Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes.
• Partner with MES engineer peers and cross-functional business partners (Supply Chain, Engineering/Process Automation, Quality, Operations) to deliver and monitor outcomes.
• Drive the site MES roadmap, incorporating digital plant initiatives such as wearables, handhelds, advanced analytics, AI, and evolving expectations for quality, safety, information security, etc.
• Provide ongoing communication on projects, issues, and major deliverables to appropriate RTP governance bodies.
• Provide Tier 2 escalated support and continuous improvement of the MES system architecture (platform, software, interfaces, and client virtualization tools) and EBRs to maintain 24x7 system availability.
• Represent RTP at MES Network Forums and within the Parenteral and Dry Product Network (PDN) to share and apply learnings.
  
  

Basic Qualifications

• Bachelor’s Degree in IT, Engineering or related discipline.
• 7+ years’ experience in IT and/or Engineering Automation/control systems related fields.
• 5+ years’ experience with design, development, testing, delivery, support of Electronic Batch Record(s) within an MES.
• Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals.
• Understanding of ISA-95 network infrastructure and internal DMZ
• Technology experience including Windows OS, Linux OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, ServiceNow.
• Willing to temporarily work irregular hours, shifts, weekends for facility startup and critical site milestones.
• 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.).
• Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus.
• Strong analytical and problem-solving skills.
• Highly motivated and self-starter.
  
  

Additional Skills/Preferences

• Experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PMX and PharmaSuite.
• Experience with manufacturing systems such as ERP, warehouse management, PLCs, automated storage & retrieval, robotics.
• Previous experience with Agile or LEAN.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Experience working in a global organization.
  
  

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 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.

Actual compensation will depend on a candidate’s education, experience, and skills. The anticipated wage for this position is $99,000 - $205,000.

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.

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 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

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