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At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Clean Utilities Lead Engineer is the site Subject Matter Expert (SME) for site GMP Utilities systems (PW, WFI, Clean Steam, 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 Clean Utilities 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 GMP Utilities.

During the day-to-day operation, the Clean Utilities Lead Engineer will be responsible for effectively, reliably and cost effectively operating the site’s GMP Utilities 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. The Clean Utilities Lead Engineer will also driving continuous improvement initiatives and local capital investment.

General

• Be the SME with a deep technical expertise in all systems under his/her responsibility (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

HSE

• 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

Basic Requirements

• Bachelor’s degree in Engineering (prefer ME, EE, Chem E) (or equivalent work experience).

• Technical understanding of Utilities

Preferred attributes but not required

• 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

• 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

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 ( LillyRecruitingCompliance@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.

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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.

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