Sr. Principal Engineer - Peptide Flow Mentor

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 35,000 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.

Position Brand Description: 

The Process Engineering Flow Mentor in IAPI (Indianapolis Active Pharmaceutical Ingredient) provides technical leadership and expertise for production operations in the areas of:  Coaching and Mentoring Front Line Process Engineers, Developing and Sustaining Process Knowledge, Process & Equipment Support, Process Optimization & Continuous Improvement, Equipment Capability & Asset Management, and Adherence to Business Systems.

Key Objectives/Deliverables:

Coach and Mentor Front-Line Process Engineers

• Coach and mentor front-line process engineers in aspects of fundamental engineering support including process understanding (both theoretical and practical), problem solving, project management, and engineering design.
• Relate experiences with troubleshooting bio-purification and traditional unit operations such as chromatography, tangential flow filtration, fermentation, homogenization, evaporation, mixing, and distillation.
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions.
• Support and peer review root cause analysis around equipment and operational events.
• Promote and peer review documentation of learning points, technical studies, and event investigations.

Develop and Sustain Process Knowledge

• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, and equipment design basis).
• Enable the development and/or maintenance of process knowledge infrastructure such as key models, report history, lab models, and literature.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Develop and support implementation of process schools.
• Support development, review, and tracking of key process engineering metrics.

Provide Process & Equipment Support

• Identify systemic issues affecting production (deviations, cycle time delays, etc.).
• Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations.  Perform reviews of event documentation for technical accuracy.
• Provide back up and shutdown support for front-line process engineers.
• Review and approve documentation/decisions requiring "Responsible Engineer" level of authority.
• Equipment includes but is not limited to: Reactors, Chromatography, Tangential flow filtration, Precipitation, Filtration and Drying.

Process Optimization & Continuous Improvement

• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation.
• Review and identify cost reduction opportunities as well as process capacities and bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
• Apply statistical thinking and methods to understand process variability and capability and drive improvements.
• Perform and promote optimization of unit operation cycle time, loading, and yield performance.
• Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.

Equipment Capability and Asset Management

• Provide technical oversight of Periodic Reviews for Direct Impact systems to ensure constant state of qualification.
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure that equipment/systems are appropriate for the intended purpose.
• Provide guidance in development of test plans for Verification packages and associated critical components.
• Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.
• Support scope development for capital projects targeted at both short and long term needs and act as user representative in some cases.
• Review and approve documentation/decisions requiring "Responsible Engineer" level of authority.

Adherence to Business Systems

• Provide engineering oversight for Process Safety Management (PSM) compliance including special requirements of Safety Critical Operation (SCO).
• Provide support for Process Hazard Review (PHR) reports and participate in PHR teams as necessary.
• Provide engineering oversight for Leak Detection and Repair (LDAR) program compliance.
• Provide support to the Process Engineer and others in the implementation of countermeasures arising from deviations, spills, and safety related events.
• Provide support to the Process Engineer and others in the implementation of recommendations from PHRs and other audit findings.
• Analyze process/unit team metrics for awareness and identification of potential improvement opportunities:
  • Cycle Time     
  • Process/Unit Emissions                     
  • Change Over Time     
  • Waste Loads
  • Schedule Conformance            
  • Customer/Partner Requirements        
  • Process Variability         
  • Event Root Causes      
  • Mass Balance of Products.

• Provide oversight in the development of technical information for the process:
  • Emissions Minimization Plans     
  • Hazard Information/Data
  • P&IDs                                   
  • Material of Construction Compatibility Matrix
  • PFDs (Equipment Flow Charts)  
  • Unit Operation Sequence       
  • Material & Energy Balances  
  • Characterizing Performance Metrics     
  • Process Safety Information         
  • Equipment Operating Procedures.
• Review and approve documentation/decisions requiring "Responsible Engineer" level of authority.

Basic Requirements:

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.
• 5+ years of work experience in an engineering, maintenance, or technical support area.
• Technical knowledge of chemical processing and process equipment.

Additional Preferences:

• Ability to apply fundamental chemical engineering principles to process understanding, problem solving and process improvement.
• Ability to function in a team environment as a leader and as a member of teams.
• Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
• Statistical thinking.
• Advocate for training and knowledge sharing.
• Communication skills.
• Develop and implement innovative approaches to problems.
• Process hazard identification/ mitigation skills.
• Successful application of root cause analysis and systematic problem solving.
• Strong computer skills in a variety of software packages (Batch Plus, JMP, Visio, Aspen, MS Project, Excel).
• Visualize an operation/process and reflect it in a model.

Other Information:

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule. Little to no travel is required with this position.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).