Lilly Consultant MES in Carolina, Puerto Rico
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 35,000 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.
Main Purpose and Objectives
The Consultant MES is responsible for organizing the development, delivery and deployment of activities associated with the Manufacturing Execution System (MES) at the Puerto Rico site. 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.
Define MES Approach
Define the MES expansion strategy for the site making sure to add value and drive the site 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 Plant Lead Team and MQ IDS Lead Team
Develop detailed project plan template that can be replicated for each implementation of MES
Conduct post-implementation After Action Reviews to gather feedback from the control room which will then be applied to future implementations
Work with other sites 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, IDS, 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 IDS solution and with the global IDS MES team
Manage MES investments and project budget for the site (including capital funding).
Act as lead for the implementation for the site. Work hand in hand with the Site manager 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 (PLT, PRLT, Global or Local MQ IDS Leadership)
Design the Future Organization
Concurrent with initial deployments, develop the long-term organization needed to support and integrate MES into the business
Design future organizational of how MES will be supported in terms of FTE required, reporting structures, relationship with global function, relationship with vendor
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
Maintain strong internal and external focus
Maintain close linkage with network sites, conduct visits.
Influence at the network level in order to advance site MES agenda and provide visibility of local need or interests.
Promote replication, standardization and simplification in global-local strategies or efforts.
Clear understanding of site MES position when compared to network sites or industry.
Conduct Benchmarking, Maintains Linkage with External Forums and bodies.
Linkage with Next GEN MES
Knowledge of cGMP's.
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.
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 IDS and/or Automation/control systems related fields.
Seven (7) years of experience in manufacturing, preferred in pharmaceutical or other regulated industries.
Seven (7) years of experience in MES (Manufacturing Execution Systems).
Computer Systems Validation in cGMP regulated operations experience.
Fully bilingual with written, verbal and oral communication skills (English /Spanish).
Excellent technical writing skills.
Excellent negotiation and presentation skills.
Ability to communicate in large group settings.
Acknowledgement of the Job Description Discussion by the employee
The acknowledgement of the Job Description discussion will be documented using Document Management System and means that he/she discussed the Job Description with their supervisor and understands the role and responsibilities associated to their job.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!