Area Engineer - Small Molecule Building - Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Area Engineer is the site Subject Matter Expert (SME) for the Small Molecules (SM) building and the associated ancillary systems within the FUME (Facilities, Utilities Maintenance & Engineering) organization.  During the project phase, the Area Engineer will be a key player in the cross functional project team in assisting in the design, construction, commissioning, qualification, start-up and operational readiness of all systems associated within the Lilly Medicine Foundry’s SM building.  During the day-to-day operation, the Area Engineer will be responsible for effectively, reliably, and cost consciously overseeing and maintaining the site’s SM building and associated ancillary systems.

This includes maintaining all systems in a state of compliance, in-control, and fit for use in order to meet the needs of internal customers and/or the business. The Area Engineer will also be responsible for driving continuous improvement initiatives and managing both annual operating expenses and local capital investments for either requested revisions and/or new functionality or capacity.  The Area Engineer will also act as the single point of contact for all residents / customers associated with the SM building.

Responsibilities:

• Be the SME with a deep technical expertise in all systems under his/her responsibility, understanding their applications in pharmaceutical manufacturing, understanding flow charts and process parameters, and awareness of industry trends including but not limited to the following building systems:

• • API Reactor Suite(s)
    • Fixed reactors and condensers (50 – 500 gallons)
  • Agitated Filter Dryers (AFD)
    • Temperature Control Units (TCU’s)
  • Solvent Filtering and Distribution
  • High Potency API Production
    • Level III containment
    • ISO 8 environment
    • Isolators and portable tanks
  • Experimental Materials Lab (EML)
    • Downflow booths
    • Walk-In / bench top fume hoods
  • Purified Water w/ Endotoxin Control (PWEC)
  • Bulk solvent distribution within the SM building
  • Gray / clean utility distribution within the SM building
  • Primary and Secondary waste streams within the SM building

• Ensure the assigned processes are aligned with Industry and Lilly Standards
• Support risk assessment exercises using the different tools available (e.g. FMEA)
• Participate as required in teams, committees, or other groups and/or individually to achieve FUME’s 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 in the SM building including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
• Develop the proper documentation (URS (User Requirement Specifications), test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and remain in a state of control.
• Contribute to the process resource assessment, capital plans, expense budgets, and prioritize as appropriate.

Daily Support for operations:

• Monitor all systems associated with the SM building and maintain KPI’s to assure that they are operating properly and in compliance with internal and external requirements.
• Act as the single point of contact for the SM building to ensure compliance related activities such as deviations, change controls and CAPA’s are resolved and implemented in conjunction with Operations, Process Engineering, Supply Chain, HSE and Quality Assurance.
• Collaborate within the FUME organization to implement efficient and effective maintenance and reliability techniques in alignment with global engineering standards.
• Apply “hands-on” problem solving skills in quickly and efficiently resolving equipment failures, troubleshooting, demonstrating RCA (Root Cause Analysis) lead investigator proficiency and guiding operations personnel in the resolution of system issues.
• Provide internal customer consultation and notifications on issues that involve critical utilities and equipment associated with the SM building.
• Assure that all necessary corrective / preventive maintenance items are identified on the proper tracking systems, and ensure activities are completed by the required dates.
• Provide technical assistance as necessary for FUME, HSE, Process Engineering and/or Operations personnel.
• Lead or participate in capital projects / changes for all systems under his/her responsibility in the SM building including project management, design, resource planning, budget adherence and Qualification/Verification activities (IQ/OQ/PQ).
• Support internal and external inspections and investigations (including Quality and HSE)
• Maintain effective and efficient communications with appropriate customer groups

Basic Requirements:

• Bachelor’s degree in Engineering (prefer ME, MET, Chem E)
• 5+ years of direct engineering experience of building, utility and chemical equipment related systems and their use in a manufacturing setting in an FDA regulated industry.

Additional Preferences:

• Previous start up experience for new building and chemical equipment related systems.
• Understanding of agile engineering techniques used in the management of buildings, utilities and equipment.
• Previous equipment installation / commissioning / qualification experience.
• Engineering experience with manufacturing / chemical plant utilities.
• Engineering related project management experience.
• Experience with CMMS (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems).
• Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites.
• Excellent interpersonal, written and verbal communication skills.
• Knowledge of cGMP principles.
• Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards.
• Strong technical aptitude and ability to train and mentor others.

Other Information:

• Temporary location in Carmel, Indiana.
• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana. 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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