Sr Principal Systems Engineer: MES Deployment

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.

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) Sr Principal Systems Engineer is responsible for the deployment of PharmaSuite MES on new and existing lines within drug product, assembly, and packaging operations. This role will leverage cross-functional global and local collaboration to deliver technical modernization, in alignment with RTP business objectives and IT standards.

Key Objectives/Responsibilities:

MES Delivery

• Provide technical oversight to development and deployment of MES Electronic Batch Record (EBR) and ancillary electronic tickets to new manufacturing lines.
• Lead migration of Electronic Batch Record (EBR) and ancillary electronic tickets for existing manufacturing lines from a legacy MES to a modern MES, according to global program timelines.
• Collaborate with cross-functional intralogistics business partners to ensure integration of PharmaSuite with existing site intralogistics system for automated material movement.
• Collaborate with cross-functional business partners in Supply Chain, Engineering/Process Automation, Quality, Operations, Learning & Development, and global counterparts to adapt existing business processes from the legacy MES to PharmaSuite.
• Provide ongoing communication on projects, issues, and major deliverables to appropriate governance bodies inside and outside the RTP site.
• Own relationship with project consultants.
• Promote a culture of compliance aligned with internal and external computer system quality standards.
• Comply with the organization’s safety goals and objectives and incorporate safety principles into MES design, as applicable.

MES Technical Leadership

• Provide PharmaSuite technical coaching to MES analysts, cross-functional MES SMEs, and Tier 1 support personnel, with emphasis on knowledge management, technical troubleshooting, accountability, and continuous improvement.
• Build relationships with MES peers at other Drug Product and Parenteral Product sites within Lilly, with an emphasis on benchmarking and knowledge sharing.
• Partner with peer MES engineers and cross-functional business partners (Supply Chain, Engineering/Process Automation, Quality, Operations) to deliver and monitor outcomes.
• Foster a continuous improvement culture through identification and adoption of process improvements, both in EBR design and MES support processes, aligned with the global design.
• Conduct benchmarking and maintain linkage with external forums and bodies.
• Influence evolution of MES within RTP and Lilly based on external benchmarking.

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) using Rockwell PharmaSuite or similar MES
• Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals.

Additional Skills/Preferences

• Experience with design, development, testing, delivery, support of Electronic Batch Record(s) using Rockwell PMX.
• Experience with manufacturing systems such as warehouse management, automated storage & retrieval, SAP, 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.
• 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.
• 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.
• Availability to travel up to 10%.

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

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.

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