MES Systems Engineer Position Available In Durham, North Carolina

Job Description:

At Lilly, we unite caring with discovery to make life better forpeople around the world. We are a global healthcare leaderheadquartered in Indianapolis, Indiana. Our employees around theworld work to discover and bring life-changing medicines to thosewho need them, improve the understanding and management of disease,and give back to our communities through philanthropy andvolunteerism. We give our best effort to our work, and we putpeople first. We’re looking for people who are determined to makelife better for people around the world.

Organization Overview:

AtLilly, we serve an extraordinary purpose. We make a difference forpeople around the globe by discovering, developing and deliveringmedicines that help them live longer, healthier, more active lives.

Not only do we deliver breakthrough medications, but you also cancount on us to develop creative solutions to support communitiesthrough philanthropy and volunteerism. Lilly is designing andbuilding a new state of the art Parenteral, Device Assembly, andPackaging Facility in Raleigh-Durham North Carolina. This is anexciting opportunity to help build a state-of-the-art facility fromthe ground up as a member of the site IT organization. TheManufacturing Execution Systems (MES) Systems Engineer isresponsible for the deployment and continuous improvement ofManufacturing Execution System (MES) electronic batch records forRTP parenteral operations. This role will pair technical mastery ofMES for drug product operations with cross-functional collaborationto expand and operationalize the MES footprint as part of theoverall site ramp up, in alignment with RTP business objectives andIT standards.

Key Objectives/Responsibilities:

MES TechnicalOwnership Provide technical oversight to development, deployment,and maintenance of MES Electronic Batch Record (EBR) and ancillaryelectronic tickets to drug product manufacturing lines. Collaboratewith cross-functional business partners in Supply Chain,Engineering/Process Automation, Quality, Operations, Learning &Development, and global counterparts to ensure MES functionalityaligns with procedures and training. Engage in lifecycle managementinitiatives to ensure a modern technology footprint aligned withcorporate and regulatory policies. Advocate for quality improvementpractices in EBR design and maintenance. Comply with theorganization’s safety goals and objectives, and incorporate safetyprinciples into MES design, as applicable. Collaborate with MESpeers, MES support personnel, and cross-functional MES colleaguesconsistent with Lilly values, emphasizing knowledge management,technical troubleshooting, accountability, and continuousimprovement. Foster a continuous improvement culture throughidentification and adoption of process improvements, both in EBRdesign and MES support processes. Partner with MES engineer peersand cross-functional business partners (Supply Chain,Engineering/Process Automation, Quality, Operations) to deliver andmonitor outcomes. Drive the site MES roadmap, incorporating digitalplant initiatives such as wearables, handhelds, advanced analytics,AI, and evolving expectations for quality, safety, informationsecurity, etc. Provide ongoing communication on projects, issues,and major deliverables to appropriate RTP governance bodies.

Provide Tier 2 escalated support and continuous improvement of theMES system architecture (platform, software, interfaces, and clientvirtualization tools) and EBRs to maintain 24×7 systemavailability. Represent RTP at MES Network Forums and within theParenteral and Dry Product Network (PDN) to share and applylearnings. Basic Qualifications Bachelor’s Degree in IT,Engineering or related discipline. 7 years’ experience in IT and/orEngineering Automation/control systems related fields. 5 years’experience with design, development, testing, delivery, support ofElectronic Batch Record(s) within an MES. Previous experiencesupporting drug product and packaging manufacturing operations forhuman health pharmaceuticals. Understanding of ISA-95 networkinfrastructure and internal DMZ Technology experience includingWindows 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 withpharmaceutical 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 influencecross-functional teams with a strong customer service focus. Stronganalytical and problem-solving skills. Highly motivated andself-starter. Additional Skills/Preferences Experience with design,development, testing, delivery, support of Electronic BatchRecord(s) using Rockwell PMX and PharmaSuite. Experience withmanufacturing systems such as ERP, warehouse management, PLCs,automated storage & retrieval, robotics. Previous experience withAgile or LEAN. Adaptability and flexibility to work in afast-paced, dynamic environment and manage multiple taskssimultaneously. Experience working in a global organization. Lillyis dedicated to helping individuals with disabilities to activelyengage in the workforce, ensuring equal opportunities when vyingfor positions. If you require accommodation to submit a resume fora position at Lilly, please complete the accommodation request form( https://careers.lilly.com/us/en/workplace-accommodation ) forfurther assistance. Please note this is for individuals to requestan accommodation as part of the application process and any othercorrespondence will not receive a response. Lilly is proud to be anEEO Employer and does not discriminate on the basis of age, race,color, religion, gender identity, sex, gender expression, sexualorientation, genetic information, ancestry, national origin,protected veteran status, disability, or any other legallyprotected status. Actual compensation will depend on a candidate’seducation, experience, and skills. The anticipated wage for thisposition is $99,000 – $205,000. Full-time equivalent employees alsowill be eligible for a company bonus (depending, in part, oncompany and individual performance). In addition, Lilly offers acomprehensive benefit program to eligible employees, includingeligibility to participate in a company-sponsored 401(k); pension;vacation benefits; eligibility for medical, dental, vision andprescription drug benefits; flexible benefits (e.g., healthcareand/or dependent day care flexible spending accounts); lifeinsurance and death benefits; certain time off and leave of absencebenefits; and well-being benefits (e.g., employee assistanceprogram, fitness benefits, and employee clubs and activities).Lillyreserves the right to amend, modify, or terminate its compensationand benefit programs in its sole discretion and Lilly’scompensation practices and guidelines will apply regarding thedetails of any promotion or transfer of Lilly employees. Lilly isdedicated to helping individuals with disabilities to activelyengage in the workforce, ensuring equal opportunities when vyingfor positions. If you require accommodation to submit a resume fora position at Lilly, please complete the accommodation request form( https://careers.lilly.com/us/en/workplace-accommodation ) forfurther assistance. Please note this is for individuals to requestan accommodation as part of the application process and any othercorrespondence will not receive a response. Lilly is proud to be anEEO Employer and does not discriminate on the basis of age, race,color, religion, gender identity, sex, gender expression, sexualorientation, genetic information, ancestry, national origin,protected veteran status, disability, or any other legallyprotected status. Our employee resource groups (ERGs) offer strongsupport networks for their members and are open to all employees.

Our current groups include: Africa, Middle East, Central AsiaNetwork, Black Employees at Lilly, Chinese Culture Network,Japanese International Leadership Network (JILN), Lilly IndiaNetwork, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQAllies), Veterans Leadership Network (VLN), Women’s Initiative forLeading at Lilly (WILL), enAble (for people with disabilities).Learn more about all of our groups. Actual compensation will dependon a candidate’s education, experience, skills, and geographiclocation. The anticipated wage for this position is $63,750 -$180,400 Full-time equivalent employees also will be eligible for acompany bonus (depending, in part, on company and individualperformance). In addition, Lilly offers a comprehensive benefitprogram to eligible employees, including eligibility to participatein a company-sponsored 401(k); pension; vacation benefits;eligibility for medical, dental, vision and prescription drugbenefits; flexible benefits (e.g., healthcare and/or dependent daycare flexible spending accounts); life insurance and deathbenefits; certain time off and leave of absence benefits; andwell-being benefits (e.g., employee assistance program, fitnessbenefits, and employee clubs and activities).Lilly reserves theright to amend, modify, or terminate its compensation and benefitprograms in its sole discretion and Lilly’s compensation practicesand guidelines will apply regarding the details of any promotion ortransfer of Lilly employees. WeAreLilly