Clean Utilities Engineer at Eli Lilly and Company

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 performance
• Engaged on communication with internal stakeholder in case of system issues and to understand their need
• Ensure 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 them
• Identify 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 recurrencies
• Technical leader and mentor for technicians
• Responsible 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 implemented
• Participate/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 required
• Develop, integrate and review SOPs, Technical Assessments and other documents on the system under his/her responsibility
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Requirements:

• Experience with Clean Utilities systems
• At 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 environment
• Solid 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/experience
• Strong 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 Friday
• Ability to work overtime and during shutdown as required
• Some 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 ( 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.

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