Sr Systems Engineer / Principal Systems Engineer: MES Deployment

Eli Lilly and Company; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Principal Engineer for their new state-of-the-art facility in North Carolina. This role involves the deployment of Manufacturing Execution Systems (MES) to enhance drug product and packaging operations. You will lead technical oversight, collaborate with various teams, and ensure compliance with quality standards, all while working in a dynamic and innovative environment. If you are passionate about making a difference in healthcare and possess the technical expertise to drive modernization, this opportunity is perfect for you.

Qualifications

• 4+ years in IT/Engineering Automation with experience in MES.
• 3+ years designing and supporting Electronic Batch Records.

Responsibilities

• Lead the deployment of PharmaSuite MES on new and existing lines.
• Collaborate with cross-functional teams to enhance manufacturing processes.

Skills

Technical Oversight

Electronic Batch Record (EBR) Development

Agile Methodologies

Analytical Skills

Problem-Solving Skills

Collaboration

Education

Bachelor's Degree in IT or Engineering

Tools

Rockwell PharmaSuite

SAP

Oracle SQL

Microsoft SQL Server

Citrix

Kepware

ServiceNow

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.

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) Principal 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

1. Provide technical oversight and input into the development and deployment of MES Electronic Batch Record (EBR) and ancillary electronic tickets to new manufacturing lines.
2. Provide technical oversight and input into the 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.
3. Collaborate with cross-functional intralogistics business partners to ensure integration of PharmaSuite with existing site intralogistics system for automated material movement.
4. Collaborate with external project consultants and 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.
5. Provide ongoing communication on projects, issues, and milestones through usage of LEAN and Agile principles.
6. Promote a culture of compliance aligned with internal and external computer system quality standards.
7. Comply with the organization’s safety goals and objectives and incorporate safety principles into MES design, as applicable.

MES Technical Support

1. 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.
2. Build relationships with MES peers at other Drug Product and Parenteral Product sites within Lilly, with an emphasis on benchmarking and knowledge sharing.
3. Partner with peer MES engineers and cross-functional business partners (Supply Chain, Engineering/Process Automation, Quality, Operations) to deliver and monitor outcomes.
4. Serve as secondary escalation contact for the 24x7 support rotation.
5. Comply with internal and external computer system quality standards.
6. Advocate for quality improvement practices in EBR design and maintenance.

Basic Qualifications

1. Bachelor's Degree in IT, Engineering, or related discipline.
2. 4+ years' experience in IT and/or Engineering Automation/control systems-related fields.
3. 3+ years' experience with design, development, testing, delivery, and support of Electronic Batch Record(s) using Rockwell PharmaSuite or similar MES.
4. Previous experience supporting drug product and packaging manufacturing operations for human health pharmaceuticals.

Additional Skills/Preferences

1. Experience designing, developing, testing, delivering, and supporting Electronic Batch Record(s) using Rockwell PMX.
2. Experience with manufacturing systems such as warehouse management, automated storage & retrieval, SAP, and robotics.
3. Previous experience with Agile or LEAN.
4. Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
5. Experience working in a global organization.
6. Experience with integrating wearable technology within manufacturing operations.
7. Understanding of ISA-95 network infrastructure and internal DMZ.
8. Technology experience including Windows OS, Linux OS, Oracle SQL, Microsoft SQL Server, Citrix, Kepware, and ServiceNow.
9. Willing to temporarily work irregular hours, shifts, and weekends for facility startup.
10. 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).
11. Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus.
12. Strong analytical and problem-solving skills.
13. Highly motivated and self-starter.
14. Availability to travel up to 10%.