Area Engineer - Small Molecule Building - Lilly Medicine Foundry
Eli Lilly and Company
Summary
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.
Job description
Responsibilities
- Be the SME with deep technical expertise in all systems under responsibility, including API reactor suites, fixed reactors and condensers, agitated filter dryers, temperature control units, solvent filtering and distribution, high potency API production, containment, isolators, experimental materials lab, fume hoods, purified water with endotoxin control, bulk solvent distribution, utility distribution, and waste streams
- Ensure assigned processes are aligned with Industry and Lilly Standards
- Support risk assessment exercises using tools such as FMEA
- Participate in teams, committees, or other groups to achieve departmental, site and/or company goals
- Lead or participate in projects/changes for all systems including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects
- Develop documentation (URS, test cases, etc.) to demonstrate systems are properly installed, qualified and started up and remain in a state of control
- Contribute to process resource assessment, capital plans, expense budgets, and prioritize as appropriate
- Monitor all systems and maintain KPIs to assure proper operation and compliance with internal and external requirements
- Act as single point of contact for the SM building to ensure compliance related activities such as deviations, change controls and CAPAs are resolved and implemented
- Collaborate within FUME to implement efficient and effective maintenance and reliability techniques
- Apply hands-on problem solving skills in resolving equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency
- Provide internal customer consultation and notifications on issues involving critical utilities and equipment
- Assure corrective/preventive maintenance items are identified on tracking systems and completed by required dates
- Provide technical assistance for FUME, HSE, Process Engineering and/or Operations personnel
- Lead or participate in capital projects/changes including project management, design, resource planning, budget adherence and Qualification/Verification activities (IQ/OQ/PQ)
- Support internal and external inspections and investigations
- 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, U/BMS and QMS
- 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
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
- Deep technical expertise in pharmaceutical manufacturing building systems
- Understanding of flow charts and process parameters
- Awareness of industry trends
- Ability to support risk assessment exercises using tools such as FMEA
- Experience developing documentation such as URS and test cases
- Experience with verification activities (IV/OV/PQ, IQ/OQ/PQ)
- Experience monitoring systems and maintaining KPIs
- Experience with deviations, change controls and CAPAs
- Hands-on problem solving and troubleshooting skills
- Root Cause Analysis (RCA) lead investigator proficiency
- Experience with corrective/preventive maintenance tracking systems
- Experience leading or participating in capital projects
- Project management, design, resource planning, and budget adherence experience
- Experience supporting internal and external inspections and investigations
- Excellent interpersonal, written and verbal communication skills
Benefits
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.