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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $167,200

Organization Overview: 

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.

This role is at the CORE Indianapolis facility, formerly Point Biopharma.  The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.  This role will report within the Facilities and Engineering team.

Responsibilities:

The process engineer provides technical oversight of the process equipment and is responsible for ensuring that the equipment remains in a qualified state to support the manufacture of radioligand therapies.

This role will engage with cross functional teams to ensure manufacturing system designs, processes, and procedures are created and accurate within established timing requirements in a GMP manufacturing facility. This engineering role will become a Subject Matter Expert on processing equipment in a clean room (classified environment) for clinical and commercial operations.    The role will be part of the cross functional process teams and will provide direct support to the production of medicine.

The role will be responsible for understanding and approving design details, assessing risk as it relates to equipment and processes, executing project tasks, managing aspects of project implementation, following quality procedures (i.e., Change Control), create and execute validation requirements, and support manufacturing systems.

The role will also be responsible for project delivery of new equipment and processes, including the development of requirements, design reviews, vendor interaction, integration and startup.

Daily Production Support

Use problem-solving tools and collaborate with Process Team members to troubleshoot and provide solutions for issues.Performance Monitoring: Establish and monitor control systems to verify and optimize equipment and system performance. Investigate and resolve equipment performance issues.Equipment owner integrating process, safety, environmental requirements and equipment knowledge. Support as a member of the cross functional process team.Participate in root cause analysis for events.Direct the integration of technical activities within the production area.

Process and Equipment Support:

Technical expert/support for installation and maintenance of process equipment and equipment improvements.Effectively communicates moderately complex technical issues and solutions to a cross functional team.Interact with production personnel to define and solve manufacturing/design issues and implement improvements.Develop training / tools for operations to transfer knowledge of equipment capabilities and operational techniques to operations and maintenance.Collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations.Prepare technical data such as qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc.Evaluate and approve design changes, specifications, and drawings.Applies engineering and scientific principles to the evaluation and solution of equipment and system problems.

Projects:

Project Management: Manage multiple projects or initiatives of varying complexity and size.Provide engineering direction from project concept through qualification on new and existing manufacturing systems.Prepare preliminary design proposals. Interact and manage vendors concerning parts or equipment they supply or propose to supply.Prepare RFP (request for proposal) and RFQ (request for quotation) documents. Participate in engineering and general design review as required.Prepare project plan, schedule, budget, and interim reports. Managing projects and creating dashboards for report outs.Understand and actively support the delivery of key site strategic initiatives.Compliance Knowledge: Possess knowledge of computer system validation and related practices, including GMP, 21 CFR Part 11 requirements.

Health, Safety and Environmental Management:

Provide technical leadership and problem-solving skills for Health, Safety and Environmental incident investigations.Lead and/or participate in process hazard reviews and other process safety activities, main resource for process safety issues on supported processes.Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.Manage the implementation of countermeasures arising from deviations, contamination, and safety related events.Maintain training compliance.

Improving the Business or Process:

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

Minimum Requirements:

Bachelor’s degree in engineering or related technology field.5+ years of experience in FDA regulated manufacturing

Additional Skills/Preferences:

Previous experience as a process automation engineer or process engineer is desirable.Previous radio pharma experience.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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