Process Engineer – Device Assembly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is a fortune 500 company in operation for 150 years creating high-quality medicines for our patients. The new facility at the Kenosha County campus will be one of Lilly’s most technically advanced manufacturing sites. The facility will include high-speed manufacturing, robotics, advanced data collection and analytics that will result in safety improvements, increased productivity, and variability reduction for Device Assembly lines. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

Responsibilities:

As the Process Engineer – Device Assembly, you will be supporting and managing the Device Assembly crucial to Lilly's supply chain. This role will be part of the LKC Site Engineering organization responsible for the delivery of the lines and support of continuous operations by providing subject matter expertise in process control, improvements, project management, and technical leadership to the process team. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment specific code and/or control system technologies. Individuals who have passion to integrate, qualify, and start up complex Device Assembly systems while serving as the technical bridge between OEM equipment, manufacturing control systems, MES, warehouse systems, and site operations are encouraged to apply.

Key Objectives/Deliverables:

• Partner with Corporate Automation, Global Packaging & Robotics, Automation Integrators, and Global Facilities Delivery to design, install, and qualify the new LKC Device Assembly lines.

• Take overall responsibility for the safe design and safe operation of the equipment within the area.

• Lead or participate in qualification activities (including commissioning activities of new equipment or areas).

• Assist in the integration of these lines into the site data collection and SCADA layer.

• Lead activities through the full project lifecycle including design review, FAT, installation, SAT, qualification, and startup support.

• Assist for integration between Device Assembly equipment and enterprise manufacturing systems including MES, warehouse management systems, scheduling systems, and site automation platforms.

• Review OEM electrical, controls, and safety designs to ensure compliance with Lilly standards and applicable industry standards (e.g., machine safety, electrical safety, and control panel requirements).

• Assist automation verification and qualification activities, including IV/OV testing, system integration testing, and startup troubleshooting.

• Support implementation and lifecycle management of Lilly manufacturing platforms such as Global Packaging Platform (GPP), GRIP, GPM, Global Scheduler, and MES integrations.

• Support manufacturing system interfaces including PLCs, HMI/SCADA systems, databases, servers, virtual environments, networks, and middleware platforms.

• Partner with Quality, Operations, Engineering, IT, OEMs, and global platform teams to resolve complex automation and integration challenges during project execution and commercial operations.

• Assist manufacturing system startup readiness activities including PSSR execution, safety verification, automation cutovers, and qualification support.

• Communicate effectively with cross functional team members in roles such as quality, logistics, and crafts personnel.

• Obtain technical expertise of equipment and processes in area of responsibility.

• Clear understanding of equipment flow chart, process flow document, critical process parameters, and equipment controls.

• Establish control charts & monitor/trend operating parameters to verify and optimize equipment performance.

• Lead troubleshooting efforts to resolve more difficult equipment and operational problems.

• Utilize formal problem-solving techniques, such as root cause analysis and causal factor charting, to resolve equipment deviations.

• Provide oversight and assist maintenance personnel and engineering techs that support the equipment.

• 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.

• Act as user representative for capital projects or local projects.

• Understand equipment reliability issues and performance KPIs.

• Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.

• Plan and coordinate equipment planned downtime windows for equipment improvements and preventative maintenance.

• Compare equipment performance data with other manufacturing sites within the network to determine areas of opportunity.

• Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance.

• Lead troubleshooting efforts to resolve more difficult equipment and operational problems.

• Utilize formal problem-solving techniques, including Root Cause Analysis, to resolve equipment issues.

• Provide oversight to Maintenance Tech/Engineering Tech(s) that support the area.

• Responsible for system/component classification and maintenance strategy for equipment.

• Drive continuous improvement initiatives by identifying root causes, implementing robust automation solutions, and improving reliability, quality, and operational performance.

• Mentor engineers and provide technical leadership across multiple manufacturing areas and project teams.

• Owner/SME of equipment, Device Assembly processes, and maintenance programs associated with Lilly Global Quality Standards (GQS) and Engineering Best Practices/Functional Standards (EBP/EFS).

• Technically lead and delegate activities to a cross-functional technical team supporting the Device Assembly lines on medium-large scale projects.

• Proficient and capable of understanding OSHA/regulatory (CFR) requirements and ensuring compliance.

Requirements (Education, Experience, Training):

• Bachelor’s degree in STEM

• 7+ years of experience as a process engineer in highly automated environment

Preferred attributes but not required:

• Technical leadership.

• Strong automation background.

• Strong learning mindset with curiosity, adaptability, and technical aptitude to rapidly acquire new skills and technologies.

• Proven experience delivering engineering projects in both greenfield and brownfield environments, including facility startup, commissioning, expansion, and retrofit initiatives.

• Ability to lead first-time processes and navigating a cross-functional team through ambiguity.

• Pharmaceutical cGMP experience and compliance OSHA and CFR knowledge.

• Project management skills.

• Adequate interpersonal and communications skills to be able to work effectively in a team-based environment.

• Strong knowledge of Studio 5000 and FactoryTalk View SE.

• Understanding of automated vision systems, and robotics.

• 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.

Additional Information:

• Schedule - 8-hour days - Monday through Friday, rotational on-call support will be required.

• Travel - Domestic and International travel may be required during startup phase (~25-50%). Domestic and International travel may be required after Operation Readiness (~5-10%).

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 () 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$66,000 - $171,600

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.

#WeAreLilly