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Clean Utilities Engineer

1 month ago

Durham, North Carolina, 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.

The Clean Utilities Engineer is responsible for maintaining the site's facility Clean Utilities infrastructure (Purified Water, WFI, Clean Steam, Pharmaceutical Compressed Air, HVAC, etc.) in a state of compliance and fit for use when needed. To achieve this, you must establish reliable operation and maintain the qualified state of the equipment and business processes in the areas, implement efficient and effective maintenance and reliability techniques, and appropriate corrective and improvement actions are taken, when necessary, in the spirit continuous improvement initiatives. Part of the responsibility of the role is the efficient and effective management of local capital allocated to Clean Utilities and oversight of engineering/maintenance contract resources assigned to the area.

Responsibilities:

Be the SME for all the systems under his/her responsibility, understanding GMP Utilities (WFI, Clean Steam, PCA, etc.) applications in aseptic manufacturing.SME on flow charts and process parameters.Ensure systems efficiency, availability and performanceEngaged on communication with internal stakeholder in case of system issues and to understand their needEnsure a safe working environment by following safety rules and helping improve the safety culture.Develop scope for capital projects targeted at both short and longer term needs. Lead or participate in projects for clean utility systems, including commissioning activities, IQ/OQ/PQ activities, as user representative for capital projects or delivery agent for local projects.Perform process monitoring - routine alarm reviews / reports. Identify and analyze KPI to measure performance against business objectives for system performances, PM, WO execution, HSE, Quality and Data Integrity aspects and evaluate projects to improve themIdentify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment & processes within the area.Responsible troubleshooting on Clean Utilities system and implement action to avoid recurrenciesTechnical leader and mentor for techniciansResponsible for the evaluation of all activities that have the potential to impact the qualified state for their system(s).Responsible for all CAPA and observation/deviation investigations and originations (e.g. root cause analysis).Change Control owner for applicable systems.Participates in Process Team.Interact with Regulatory Agencies during site inspections as Clean Utilities.Responsible for periodic reviews of systems and procedures.Responsible for equipment reliability issues & maintenance strategy, responsible to have WO are correctly closed before the due date and the maintenance programs are adequately implementedParticipate/Provide oversight in ensuring scheduled shutdowns are planned and executed effectively.Interface with external contractors in case of needs or involve them on projects when requiredDevelop, integrate and review SOPs, Technical Assessments and other documents on the system under his/her responsibilityResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Basic Requirements:Experience with Clean Utilities systemsAt least 2 years in Engineering and/or Maintenance experience. Education Requirements:Bachelors degree in Engineering Additional Skills/Preferences:Relevant experience operating in an FDA regulated environmentSolid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.Previous facility start up experience.Previous equipment qualification and process validation experience.Previous experience with deviation and change management systems including Trackwise.Reliability Centered Maintenance (RCM) exposure/knowledge/experienceStrong problem solving skills.Good interpersonal and communications skills.Ability to work effectively in a cross-functional environment.Ability to communicate effectively with all levels of the organization.Strong computer skills in a variety of software packages (SAP, Excel, etc.), previous experience with Computerized Maintenance Management Systems (i.e. MAXIMO).Additional Information:Ability to work 8 hour days – Monday through FridayAbility to work overtime and during shutdown as requiredSome travel required for facility start-up activities 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 ( ) 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