Principal Civil Engineer- API Manufacturing

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. Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Responsibilities

• Support daily operations including equipment troubleshooting and root cause failure analysis to assure technical availability.
• Work with process engineers to improve regulatory compliance, reliability, and safety.
• Monitor and report assigned cost center metrics on a regular basis.
• Responsible for meeting site objectives in core areas of small capital project delivery, plant engineering support, equipment reliability, improvement of equipment systems, and key support for productivity projects utilizing both external and internal resources in assigned area.
• Make and influence key decisions and take responsibility for time schedule, costs, quality, and plant/area operability.
• Initiate and foster a continuous improvement and optimization process in assigned area.
• Initiate and introduce standards, tools, procedures, safety, cGMP and compliance initiatives in assigned area.
• Develop and maintain engineering specifications, standards, and equipment work instructions that are designed to increase equipment uptime and reduce maintenance and spare part costs.
• Responsible for development of the investment and asset strategy for current and future business in assigned area.
• Keep facility and building systems up to applicable standards as assigned.
• Comply with all applicable codes, regulations, governmental agency, and company directives related to building operations and work safety.
• Apply in-depth knowledge of standard principles and techniques/procedures to accomplish complex assignments and provide innovative solutions.
• Review inspections of building systems including fire alarms, HVAC, and plumbing to ensure operation of equipment is within design capabilities and achieves environmental conditions prescribed by client.
• Originate/ develop technical changes, improvements, along with supporting documentation.
• Provide technical expertise for change management and small capital project coordination through design, construction, commissioning, qualification, and start up.
• Generate detailed scope of work documents for capital and expense-based projects.
• Serve as project responsible, project manager, or consultant when necessary on capital projects and plant expense-based projects.
• Participate in Process Hazard Analysis, Layer of Protection Analysis and Hazard and Operability Study.
• Utilize technical skills in troubleshooting, specifying replacement equipment, strategic planning, and supporting the overall mechanical integrity process.
• Provide facility engineering expertise in support of the elements of OSHA PSM (MOC’s, PHA’s, PSSR’s, P&ID’s, PSI, etc.).
• Conduct incident investigations and RCA determination.
• Complete assigned action items related to safety and equipment reliability.
• Manage maintenance costs and budget planning for assigned building(s)/area.
• Implement the preventive maintenance program to ensure that building machinery and systems meet or exceed their rated life.
• Complete structural assessments for plant activities like safety tie off points, overhead hoists, and critical crane lifts.
• Organize and lead emergency repairs as needed.
• Develop a maintenance strategy for assigned building(s)/area.
• Provide mechanical integrity expertise and implement the plant-wide mechanical integrity strategy.
• Execute a site asset integrity strategy and improve site mechanical integrity processes, for both near-term and long-term planning.
• Maintain and repair mechanical, plumbing, structural, furniture, fire, life safety, and control systems.
• Provide technical support for maintenance activities.
• Conduct inspection, monitoring, maintenance, and repair according to the latest safety standards.
• Ensure plant equipment is test and inspection compliant with all applicable codes and standards, such as, mechanical integrity, RAGAGEP and OEM.
• Prescribe, maintain and improve predictive and preventative maintenance for equipment that maximizes the life of the asset.
• Apply Risk Based Maintenance to unit assets.
• Design and oversee the construction of infrastructure projects such as roads, bridges, and water systems.
• Conduct site inspections to ensure compliance with engineering standards and specifications.
• Use engineering software and tools to create blueprints and models.
• Analyze survey reports, maps, and other data to plan projects.
• Ensure that all civil engineering projects adhere to legal guidelines and safety standards.
• Collaborate with architects, contractors, and other stakeholders.

Requirements

• Bachelor’s degree in Engineering (Civil Engineering preferred)
• 5+ years of experience in civil engineering, preferably in a regulated manufacturing environment

Nice-to-haves

• Professional Engineer (PE) license preferred.
• Proficiency in engineering software and tools.
• Strong project management and organizational skills.
• Excellent communication and interpersonal skills.
• 4+ years extensive progressive chemical process and plant experience.
• Emergency Response or Emergency Operations Center Experience.
• Previous experience in facility/area start-up environments.
• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to prioritize, set objectives and meet targets.
• Ability to provide high level customer service.
• Knowledge of Good Manufacturing Practices (GMP).
• Possess a highly effective knowledge of plant design, production, project management, maintenance management, policies and standards in assigned area.
• Demonstrated technical, analytical, and problem-solving skills to maintain customer, area, and business needs.
• Skills in successfully overcoming challenges and identifying opportunities for improvements.
• Ability to implement the fundamentals of project management and plant engineering.
• Ability to complete structural assessments for plant activities like safety tie off points, overhead hoists, and critical crane lifts.
• Experience with the following systems: GMARS, Service Insight, GECMS, TrackWise, Veeva Vault, Serra view, Spar Requests, Asset Recovery, Lilly Stores, Delta V, Metasys BMS, Coupa Purchase Orders, E-peers, B-Safe, Gensuite, and SAGE Steam Monitoring.

Benefits

• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Company bonus (depending, in part, on company and individual performance)