Area Engineer, Biologics Building - Lilly Medicine Foundry

Eli Lilly and Company • Lebanon, IN

15d • $66,000 - $171,600

About The Position

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. Organization and Position Overview 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 Biologics Building (BB) 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 BB. During the day-to-day operation, the Area Engineer will be responsible for effectively, reliably, and cost consciously overseeing and maintaining the site’s BB 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 BB. 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 / equipment systems: Process Rooms ISO 7/8 Flexible Spaces Single Use Bioreactors (SUBs) (50L – 2000L) Single Use Mixers (SUMs) Chromatography Columns Organic Solvents Bio Safety Cabinets (BSCs) Gas / Temperature Control Units (TCUs) Material Dispensing Cold room(s) / freezers BSC’s and fume hoods Drum handling Media Prep Agitated vessels Portable SUMs TCUs Buffer Prep Cell Bank Cryovial Storage System Process Utility Areas Clean in Place (CIP) Caustic Dilution System Water for Injection (WFI) Waste Systems Compressed Gas Systems Oil Free Compressed Air Nitrogen (N2) – Bulk Liquid Oxygen (O2) – Bulk Liquid Carbon Dioxide (CO2) – Bulk Liquid

Requirements

• Bachelor’s degree in Engineering (prefer ME, MET, Chem E)
• 5+ years of direct engineering experience of building, utility and chemical / biopharma equipment related systems and their use in a manufacturing setting, pharma preferred.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Previous start up experience for new building and biopharma 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 / biopharma 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.

Responsibilities

• 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.
• Lead or participate in projects/changes for all the systems under his/her responsibility in the BB including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
• Develop the proper documentation User Requirement Specifications (URS), 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.
• Monitor all systems associated with the BB 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 BB in order 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 in order 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 BB.
• 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 to FUME, HSE, Process Engineering and/or Operations personnel.
• Lead or participate in capital projects / changes for all systems under his/her responsibility in the BB 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 site customer groups

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level