Engineering Systems Lead

1 month ago

Durham, United States Eli Lilly and Company Full time

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 unites caring with discovery to create medicines that make life better for people around the world.  Lilly is a fortune 500 company that has been in operation for over 140 years.  We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up.

The Engineering Systems Lead is responsible for the staffing, training, and leadership of the CQV contractors.  The Engineering Systems Lead is also responsible for supporting asset delivery, process development, commissioning, qualification, validation/verification and startup of the organization and site.  After startup, the Engineering Systems Lead will be responsible for supporting the day-to-day engineering organizational activities, being the site SME of engineering systems/programs and helping to train, onboard, develop and guide the organization’s engineers and technicians.

Key Objectives/Deliverables:

Technical Lead for CQV, Verification and Training ProgramsSupport capital project delivery by onboarding and managing CQV resourcesVerification Strategy SMEKneat Power UserTraining lead for special OJT skills such as temperature mapping and defect analysis in visual inspectionGlobal Parenteral Network training leadEstablish RTP Engineering Strategies and Alignment to StandardsManage vendor responsible for engineering drawingsManage the RTP instance of the GECMSParticipate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).Manage mapping RTP practices and procedures to engineering standardsEnsure Alignment to Tech Center resourcesManage and establish the asset qualification monitoring program at the RTP site, train users of the program and serve as the site SMEMaintain metrics to measure performance against business objectives and make necessary changes to improve performance.Enable the Success of RTP Team LillyDevelop an engineering onboarding programSite MSOE leadAny other responsibilities to support the success of the RTP organization

Minimum Requirements:

At least 7 years of engineering/CQV experience

Additional Preferences:

Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment.Previous facility or area start up experience.Previous experience with Manufacturing Execution Systems and electronic batch release.Previous management or leadership experience including leading or working effectively with a cross functional groupExcellent interpersonal, written, and oral communication skillsAbility to work using own initiativeStrong technical aptitude and ability to train and mentor othersAbility to balance a number of priorities and tasks simultaneouslyPrevious experience with deviation and change management systems including Trackwise.

Education Requirements:

Bachelor's degree in engineering

Other Information:

Ability to work 8-hour days – Monday through FridayAbility to work overtime as required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly

  • Engineering Systems Lead

    3 days ago

    Durham, United States Eli Lilly Full time

    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...

  • Senior/ Lead Process Engineer

    18 hours ago

    Durham, United States Elo Life Systems Full time

    THE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...

  • Senior/ Lead Process Engineer

    11 hours ago

    Durham, United States Elo Life Systems Full time

    THE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...

  • Senior/ Lead Process Engineer

    6 hours ago

    Durham, United States Elo Life Systems Full time

    THE ROLEReporting to the SVP, Global Manufacturing, Operations and Regulatory, the Senior/Lead Process Engineer will be a key member of the Manufacturing team. This role will be responsible for developing and managing Elo’s pilot studies (bridging with R&D on bench studies) as well as scaling and optimizing ingredient production to meet commercial...

  • Lead Technical Consultant

    2 days ago

    Durham, United States Alphanumeric Systems Inc. Remote Work Freelance Full time

    Alphanumeric is hiring a LEAD TECHNICAL CONSULTANT to work remotely out of the Research Triangle Park, NC area with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.We are seeking a highly skilled and experienced Technical Product Manager for our Generative AI product, Jules, being developed with AIML, In...

  • Lead Technical Consultant

    1 day ago

    Durham, United States Alphanumeric Systems, Inc. Full time

    Job DescriptionJob DescriptionAlphanumeric is hiring a LEAD TECHNICAL CONSULTANT to work remotely out of the Research Triangle Park, NC area with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.We are seeking a highly skilled and experienced Technical Product Manager for our Generative AI product, Jules,...

  • GxP Systems Lead

    5 days ago

    Durham, United States Randstad Life Sciences US Full time

    6 month ContractHybrid (Durham or Dallas local)Systems they will use:Sharepoint for GMPMicrosoftTableauVeevaDocusignOne DriveTeamsLittle bit of configuring involved. Working with the user groups for testingOwner and administrator of GMP systems.What Skills or Experience MUST our candidates have to be qualifiedIT Skills/Knowledge background in Biotech,...

  • GxP Systems Lead

    5 days ago

    Durham, United States Randstad Life Sciences US Full time

    6 month ContractHybrid (Durham or Dallas local)Systems they will use:Sharepoint for GMPMicrosoftTableauVeevaDocusignOne DriveTeamsLittle bit of configuring involved. Working with the user groups for testingOwner and administrator of GMP systems.What Skills or Experience MUST our candidates have to be qualifiedIT Skills/Knowledge background in Biotech,...

  • System Engineer

    2 weeks ago

    Durham, United States Kyyba Full time

    Title: System Engineer Location: Durham, NC (Onsite) Job Role: Contract Position Job Description Provide technical support in the development of robotic device including motors, motor drives and motion control mechanisms Understand the kinematics of the existing system and provide support in electrical, electromechanical, gear drive calculations and in...

  • GxP Systems Lead

    18 hours ago

    Durham, United States Beacon Hill Full time

    To be successful in this role, the candidate will possess a patient-focused Quality mindset, technical expertise, communicate clearly and effectively (in verbal and written form), and display exemplary organizational and leadership skills. The candidate will contribute to an environment in which the team is highly motivated and engaged to work...

  • GxP Systems Lead

    1 week ago

    Durham, United States Beacon Hill Full time

    To be successful in this role, the candidate will possess a patient-focused Quality mindset, technical expertise, communicate clearly and effectively (in verbal and written form), and display exemplary organizational and leadership skills. The candidate will contribute to an environment in which the team is highly motivated and engaged to work...

  • System Engineer

    1 day ago

    Durham, United States Nutanix Full time

    Systems Engineer - MACHungry, Humble, Honest, with Heart.The Opportunity Are you a passionate Mac enthusiast with strong expertise in JAMF and MacOS engineering? If so, join our Nutanix IT EUC Engineering team and be a part of an opportunity to provide world-class support and engineering to our Mac users, while working with cutting-edge technologies in a...

  • Sr Mechanical Engineer 2

    2 weeks ago

    Durham, United States Sunrise Systems Full time

    Our client, a leading Medical Devices Manufacturing Company is looking for Sr Mechanical Engineer and This is for an initial duration of Months at Durham, NC   Job Title: Sr Mechanical Engineer Job Id: - Location: Durham, NC Duration: Months Contract Position Type: Hourly Contract Position (W only) Onsite daily Description: As a...

  • Senior Systems Engineer

    1 day ago

    Durham, United States Fidelity TalentSource LLC Full time

    Job Description:Position Description: Provides system production support using Cloud-based technologies -- SaaS solutions for Cloud providers. Coordinates work flows using Continuous Integration and ContinuousDeployment (CI/CD) pipelines and associated technologies. Scripts in PowerShell, Python, and Java. Supports application production using Docker,...

  • EDA System Software Engineer

    2 days ago

    Durham, United States NVIDIA Full time

    EDA System Software Engineer page is loaded EDA System Software Engineer Apply locations US, NC, Durham US, MA, Westford US, TX, Austin US, CA, Santa Clara time type Full time posted on Posted 2 Days Ago job requisition id JR1980536 NVIDIA has continuously reinvented itself over two decades. Our invention of the GPU in 1999 sparked the growth of the PC...

  • Senior Systems Support Engineer

    3 weeks ago

    Durham, United States JobRialto Full time

    The Role Ideal candidates will have a background in either systems engineering or software engineering with a desire to learn and understand the other or previous experience as a systems engineer or SRE. We are looking for a Systems Thinking Leader who has helped teams scale through production insights, operational automation, developer guidance, real-time...

  • Power Systems Engineer, US

    1 week ago

    Durham, United States Smart Wires Full time

    Do you want to make a positive impact? Are you interested in helping us achieve our vision of a highly efficient grid that powers a cleaner planet? Do you want to work in a collaborative environment surrounded by colleagues who are creative, focused and mission-driven? If so, read on to see if this might be the job you have been dreaming about. We are in the...

  • Power Systems Engineer, US

    4 weeks ago

    Durham, United States Smart Wires Inc Full time

    Job DescriptionJob DescriptionDo you want to make a positive impact? Are you interested in helping us achieve our vision of a highly efficient grid that powers a cleaner planet? Do you want to work in a collaborative environment surrounded by colleagues who are creative, focused and mission-driven? If so, read on to see if this might be the job you have been...

  • Systems Test Engineer 4

    1 day ago

    Durham, United States Nutanix Full time

    Hungry, Humble, Honest, with Heart.The Opportunity Are you a proactive and detail-oriented QA Engineer with experience of testing enterprise-level software? If so, join our team at Nutanix and work alongside brilliant software engineers in a fast-paced environment, where you'll have the autonomy to build automation and break cutting-edge data protection...

  • Principal Systems Engineer

    2 weeks ago

    Durham, United States Fidelity Corp Full time

    Job Description: Principal Perimeter Security Engineer The job involves performing functions related to Network and Perimeter specialized Security Engineers, including Web Application Firewall, Network and cloud security. Looking for an energetic, hard charging individual able to keep up in an exciting and fast-moving security operations team that is...