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.
The Lead Process Engineer role is responsible for establishing and maintaining the reliable operation and qualified state of the equipment and business processes for the Vault automated device assembly manufacturing process team at the Indianapolis Device Assembly and Packaging (IDAP) site. The Lead Engineer ensures that equipment is in-control, compliant, and capable of meeting customer needs, while also driving associated continuous improvement effort. Additionally, the Lead Engineer serves as the technical leader for the engineering process team and leads project prioritization and strategic continuous improvement planning while also mentoring the frontline engineers (Process and Automation) of the process team.
Ensure a safe working environment by following safety rules and helping improve the safety culture.
Actively participate in safety-related activities (audits, JSA’s, hazard reviews, etc.) to drive ongoing safety improvement.
Take overall responsibility for the safe design and safe operation of the equipment within the area.
Provide engineering expertise as active member of area process team.
Obtain technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance.
Lead troubleshooting efforts to resolve more difficult equipment and operational problems.
The Maintenance Tech/Engineering Tech is the first line of support in troubleshooting and involves the Engineer - Process as needed.
Utilize formal problem solving techniques, including Root Cause Analysis, to resolve equipment issues.
Respond to and implement customer requests related to the equipment.
Communicate effectively with others, especially process team members, customers, engineering tech, and crafts personnel.
Provide oversight to Maintenance Tech/Engineering Tech(s) that support the area.
Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools/processes as necessary (change control, hold, etc.).
Responsible for system/component classification and maintenance strategy for equipment.
Implement corrections, corrective actions, and countermeasures arising from CAPA’s.
Participate in Periodic Reviews for equipment.
Lead or participate in IQ/OQ/PQ activities (including commissioning activities of new equipment or areas).
Develop scope for capital projects targeted at both short and longer term needs.
Act as user representative for capital projects or delivery agent for local projects.
Understand equipment reliability issues with the objective of improvement.
Coordinate with site/corporate asset management personnel to replicate improvements and assure alignment of maintenance and other equipment activities
Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
Compare equipment performance data with that of other operations to determine areas of opportunity.
Goals/objectives should target world-class levels of operation.
Bachelors Degree in STEM discipline (Engineering preferred)
2 years of manufacturing experience
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.
Technical leadership experience.
Strong computer skills in a variety of software packages (Excel, JMP, etc.).
Ability to work in a safe manner to ensure the safety of self and others.
Previous experience as a process or automation engineer within the Pharmaceutical Industry.
Strong troubleshooting skills.
Ability to apply statistical thinking concepts to the analysis of manufacturing problems.
Experience in utilizing root cause analysis techniques for the systematic solving of problems.
8 hour days with after-hour support as needed.
Occasional travel may be required for training, conferences, capital projects, etc.
Note: When applying internally for a position your current supervisor receives notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.
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.
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).
Req ID R-31555