Lilly Utilities Engineer in Concord, North Carolina
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.
The Utilities & HVAC Lead Engineer is the site Subject Matter Expert (SME) for site HVAC (GMP and non GMP) and Utilities systems, both GMP (PW, WFI, Clean Steam, Process Compressed Air, etc..) and non GMP (Plant Steam, Chilled Water, Water, Waste Neutralization, sewer, etc…), and the ancillary systems associated within their facilities. It has specific responsibility in the project phase of construction of the new site and after project completion during site day-to-day operation.
During the project phase the Utilities & HVAC Lead Engineer will be a key player in the cross functional project team in charge of the design, construction, commissioning, qualification, start-up and operational readiness of all site utilities and HVAC systems.
During the day-to-day operation, the Utilities & HVAC Lead Engineer will be responsible for effectively, reliably and cost effectively operating the site’s HVAC (GMP and non-GMP) Utilities (GMP and non GMP) and ancillary systems associated within their facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. Utilities & HVAC Lead Engineer will also driving continuous improvement initiatives and local capital investment.
Be the SME with a deep technical expertise in all systems under his/her responsibility (GMP and non-GMP HVAC, GMP and non GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends.
Ensure the assigned processes are in alignment with the Industry and Lilly Standards
Support risk assessment exercises using the different tools available (eg.FMEA)
Participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals
Initial project asset delivery phase and future local capital investment.
Lead or participate in projects/changes for all the systems under his/her responsibility including Design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state
Contribute to the process resource assessment, capital plans, expense budgets, and prioritize appropriate
Daily Support to operations:
Monitor utility systems and maintain KPI’s to assure that they are operating properly, in compliance with requirements.
Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters
Implement efficient and effective maintenance and reliability techniques,
Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
Provide customer consultation and notifications on issues that involve utilities areas assigned
Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date
Provide technical assistance as necessary to maintenance, and operations personnel
Support internal and external inspections and investigations (including Quality and HSE)
Maintain efficient communications with appropriate site customer groups
Proficiency with the Trackwise and CAPA systems
Process Monitoring and Technical support:
Capable of data mining, data analysis, process monitoring, and lead process control tuning parameters
Assure that there is adequate site generation and distribution capacity by monitoring the site usage and staying abreast of future site requirements. This includes providing information for the site utilities master plan and reviewing the information provided by the customers as to their current and future demands.
Consult on technical issues with operators, responsible engineers, and crafts
Maintain, develop, and conduct operations training of utility systems
Utilize statistical analysis tools to determine the process control, and capability for investigations
Comply with and support departmental HSE plans
Ensure the systems comply with all Health, Safety and Environmental policies and procedures, and knowledge of Process Safety Management processes. (i.e., PSSR, GIPSM, CPH, etc.)
Technical resource during process hazard reviews
Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership
Identify risks and escalate situation with a sense of urgency
Education Requirements : Bachelor’s degree in Engineering (prefer ME, EE, Chem E) (or equivalent work experience).
Technical understanding of HVAC and Utilities
Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites
Excellent interpersonal, written and verbal communication skills
Knowledge of cGMP
Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards
Strong technical aptitude and ability to train and mentor others
Preferred attributes but not required
Previous start up experience
Engineering experience in the pharmaceutical industry
Previous equipment commissioning experience
Engineering experience with manufacturing plant utilities
Project management experience
Experience with maintenance and computerized maintenance management systems (CMMS)
Previous experience with deviation and change management systems including Trackwise
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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 (subject to applicable law).