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Manufacturing Execution Systems Lead-IDS

Durham, North Carolina

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Req ID R-5122 Title Manufacturing Execution Systems Lead-IDS City Durham State / Province North Carolina Country United States

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 39,000 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 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  and Quality System from the ground up. 

The Manufacturing Execution Systems (MES) Lead is responsible for organizing the development, delivery and deployment of activities associated with the Manufacturing Execution System (MES) at RTP.

The person will be responsible to define the requirements needed for the MES implementation. The responsibilities include leading the implementation, managing staffing, define funding requirements, communications, etc.

The person will represent RTP at internal MES Product Network forums and other relevant external forums. 

Key Responsibilities

Define MES Approach

Define the MES expansion strategy for RTP in conjunction with the Global MES teams making sure to define and add value and drive the sites productivity agenda.

Develop Detailed Project Plan

Develop both a high level roadmap and detailed project plan containing the plan to deliver MES across the site.

  • Develop overall “road map” that can be shared with RTP Site Lead Teams, MQ IDS Lead Team and Global MQ IDS MES team
  • Develop detailed project plan template that can be replicated for each implementation of MES on the lines at RTP
  • Conduct post-implementation After Action Reviews to gather feedback from the control room which will then be applied to future implementations
  • Work with sister sites in the Parenteral Product Network (PPN) to apply learnings from their deployment plans and execution of those plans
  • Generate and maintain the project plan(s) for each deployment

Resource Management and Financials

Develop a resource plan for both the implementation at a process step, the support of multiple concurrent implementations, and the overall resource requirements for full site implementation and daily support.

  • Develop and maintain a detailed (month by month) resource plan which includes human resources (local, global, IT, business area, contract, Lilly) for implementation at a process step and overall implementation planning
  • Staff the MES Team accordingly by working with peer management to obtain the appropriate talent for the project
  • Build and maintain strong relationships with external vendor that supplies IT solution and with the global MQ IDS MES team
  • Manage MES investments and project budget (including capital funding).

Lead Implementation

Act as lead for the implementation for the site.  Work hand in hand with the Site managers in managing the resources and communications of the project.

  • Define the governance of the execution of the MES agenda including items like: communication plan to stakeholders, scorecard, promotion of program to the global organization and site employees, etc.
  • Oversee the execution of the MES project by providing appropriate updates on status and progress
  • Escalate issues to appropriate governance bodies (Site Lead team, Global or Local MQ IDS Leadership)

Design the Future Organization

Concurrent with initial deployments and working with the MQ IDS RTP Director, develop the long-term organization needed to support and integrate MES into the business

Build Digital Plant Capabilities

Advance the MES agenda with the intention to build digital plant capabilities like electronic batch disposition. Be able to incorporate all elements of our business in order to build integrated solutions: Automation, Laboratories, Supply Chain, etc.

External Focus

Maintain strong internal and external focus

  • Represents RTP at MES Network Forums
  • Maintain close linkage with network sites, conduct visits.
  • Influence at the network level in order to advance RTP agenda and provide visibility of local need or interests.
  • Promote replication, standardization and simplification in global-local strategies or efforts.
  • Clear understanding of RTP position when compared to network sites or industry.
  • Conduct Benchmarking and maintains Linkage with External Forums and bodies.

Quality

  • Promote a culture of compliance and advocate for quality improvement practices across the organization
  • Comply with all applicable internal and external computer systems regulations.
  • Comply with Good Manufacturing Practices and Good Documentation Practices.
  • Comply with local management responsibilities outlined in the Lilly Quality Practices and Standards.

Safety

Comply with the requirements established in the Security Policy, Occupational Safety and Industrial Hygiene Policy, Standard Operational Procedures (SOPs) and Basic Safety Rules, including:

  • Comply with the safety goals and objectives of the organization
  • Monitor personal performance in the industrial health and safety area.
  • Notify and initiate actions to correct any hazard conditions/risks in my working area.
  • Actively participate in the safety trainings applicable to my area.
  • Notify Management of any emergency incident, register, and comply with the communications requirement.

Additional Preferences:

  • Knowledge of cGMP's.
  • Knowledge of software tools such as Word, EXCEL, Lotus Notes, Visio, PowerPoint, Microsoft Project.
  • Knowledge of Project Management and Leadership skills is highly recommended.
  • Knowledge on Pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.)
  • Willing to travel.
  • Willing to work irregular hours, shifts, weekends, holidays, when necessary.
  • Highly motivated and self-starter.
  • Strong customer service and teamwork oriented.
  • Available to provide on call support during weekends, and after working hours.

Basic Requirements

  • Bachelor’s Degree in Business Administration with Major in Computerized Information System, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
  • Ten (10) years of experience in IT and/or Automation/control systems related fields.
  • Seven (7) years of experience in manufacturing, preferred in pharmaceutical or other regulated industries.
  • Computer Systems Validation in cGMP regulated operations experience.

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-5122.

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.

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