B132 Process Engineer - IAPI - Night Shift

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.

Provides technical oversight of the process equipment and is responsible for ensuring that the equipment remains in a qualified state in order to support the manufacture of bulk drug substance.

Key Objectives/Deliverables:

Process and Equipment Support:

• Equipment owner integrating process, process safety, environmental requirements and equipment knowledge.
• Monitor established equipment systems for process indicators to identify potential issues affecting production.
• Investigate and resolve equipment performance issues.
• Technical expert/support for installation and maintenance of process equipment and equipment improvements.
• Develop training / tools for operations to transfer knowledge of equipment capabilities and operational techniques to operations and maintenance.

Improving the Business or Process:

• Identify/Implement improvement projects for capacity, product quality, raw material cost, emissions/waste loads, process variability and process safety.
• Perform and summarize improvement opportunities in technical reports
• Understand process/unit capacity constraints.
• Lead or participate in equipment/process qualification activities (including commissioning activities of new equipment or areas).

Health, Safety and Environmental Management:

• May provide the technical leadership and problem solving skills for Health, Safety and Environmental incident investigations.
• Perform compliance related technical tasks such as emissions calculations, equipment evaluation, and application of material balances for env needs.
• Lead and/or participate in process hazard reviews and other process safety activities, main resource for process safety issues on supported processes.

Adherence to Business Systems:

• Manage the implementation of countermeasures arising from deviations, spills, and safety related events.
• Manage the implementation of recommendations from PHRs and other audit findings.
• Maintain training compliance.
• Maintain and establish the equipment technical information for the process;
• Equipment procedures, P&IDs, Material of Construction Compatibility Index, Equipment information in PFDs, Aspen models, Material & Energy Balances, Process Safety Information

Basic Requirements:

• Bachelor of Science Degree in Engineering
• 2+ years of pharmaceutical manufacturing (or equivalent), preferably in API

Additional Preferences:

• Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement.
• Ability to function in a team environment
• Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
• Available on call to address processing emergencies over the phone and at times return to the plant during off-hours.
• Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning and Qualification, Routine Data Monitoring
• Ability to apply statistical thinking concepts to the analysis of manufacturing processes
• Visualize an operation/process and reflect it in a model
• Root cause analysis and the problem solving
• Process Hazard Identification/ Mitigation Skills
• Strong Computer skills in a variety of software packages (Batch Plus, JMP, Visio, PI Data Historian, MS Project, Excel)
• Experience with normal processing equipment/unit operations

Other Information:

• This position serves an extended coverage night shift position. Shift premium is included for this position. Situations may arise where off-schedule work, both on-site and off-site, will be required.
• This position requires little to no travel.
• Tasks require entering manufacturing and laboratory areas, which require wearing appropriate PPE and the ability to access plant operating equipment including climbing of stairs and ladders.
• This position requires 24/7 availability via cell phone.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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