Associate Director - Process Engineering

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.

Main Purpose and Objectives

Responsible for leading the Process Engineering group (frontline operations and/or projects), establishing and sustaining systems to ensure reliable operations and the qualified state of process equipment on site. Ensures that process equipment is in control, compliant and capable of meeting plant production requirements while also driving continuous improvement efforts. Additionally, will influence other functional disciplines to support the process engineering technical agenda, and site business plan objectives.

Responsibilities

Support to Production Process

• Provide oversight to process equipment to ensure clear understanding of equipment flow, process flow, and critical process requirements across all process steps on site.
• Provide oversight of engineering standards that are applicable across each process team.
• Establish control systems to monitor, trend and verify process equipment performance.
• Ensure asset qualification review process is performed across all process steps on site.
• Support and/or lead troubleshooting efforts to resolve equipment and operational problems and align trouble-shooting activities with TS/MS, Process Automation, Maintenance/Reliability, Quality, etc. as required.
• Ensure formal problem-solving techniques, such as Root Cause Analysis and FMEA are utilized to resolve equipment issues.
• Respond-to, understand and deliver customer requests related to the process equipment.
• Ensure projects are delivered on schedule. Maintain financial oversight of Process Engineering group projects against plan commitments within the SAP system and in compliance with financial policy.
• Participate, as required in assigned teams and support the deliverables defined for the year.
• Support Environmental Health and Safety (EHS) agenda (e.g. Dust Explosion; Industrial Ergonomics; Containment) for the site.
  • Example of areas the manager leads/facilitate:

Identify and assign appropriate resources for the implementation of the programs. Understanding of the program, its requirements, and policies. Establish annual goals and objectives. Participate in the Self Audits, if needed. Ensure related EHS Plan actions are completed on time. Support event reporting, investigation, and CAPA cycle.

• Understand the Site's EHS requirements and policies and lead efforts toward the continuous improvement of the agenda for those areas.

Improve the Business:

• Conduct periodic Gemba walks and apply lean principles and tools (ie, A3, DMS) to drive improvements.
• Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment and processes across site.
• Compare equipment performance data with that of other operations to determine areas of opportunity. Goals/objectives should target world-class levels of operation.
• Participate as part of PR01 Engineering Lead Team & Lilly del Caribe Engineering Teams. Provide an active role in defining and delivery of objectives and goals defined for the year.
• Work in collaboration with Engineering Tech Center to drive continuous improvement agenda, share lessons learned events & best practices.

Administrative Leadership

• Will develop an organization in line with the Lilly Values, and using technical knowledge, skills, and consistent processes to ensure delivery of the site goals and personal growth needs.
• Lead the performance management process for Process Engineers.
• Work on development plans and career path development.
• Ensure that people in responsible positions are qualified.
• Ensure training compliance & learning plan alignment.
• Manage resources effectively.
• Support & lead site initiatives & GMP Plan.
• Hold team accountable to goals & objectives.
• Understand Manufacturing Standards for Operational Excellence (MSOEs) and ensure a periodical assessment of the process engineering function compliance with the MSOE standards.

Management of Controlled Substances, if applicable

Comply with all established requirements to receive and maintain authorization to handle controlled substances.

a. Successfully complete the background check process.

b. Complete the trainings assigned to your learning plan within the established due dates.

c. Report drug diversion.

d. Report illicit activities by employees.

Educational Requirements

BS in Engineering (Mechanical, Chemical or related).

Experience Requirements

• At least 6 (six) years on pharmaceutical industry Engineering or equivalent experience on Technical Services or Quality/Regulatory Areas.
• At least 3 (three) years on Drug Product Solid Operations (including experience on Drug Product Solid Operations facilities/equipment design, construction and start up) is preferred.
• Experience with design, qualification, Process/Cleaning Validation for the following systems/equipment is preferred:
  • Mixers
  • Fluid Bed Drying
  • Fluid Bed Granulators
  • Precision coaters
  • Compression
  • Capsule Filling
  • Coating
  • Imprinting
  • HVAC systems
• Technical experience on process and technology transfers/introductions on pharmaceutical operations.
• Multi areas project management and areas integration and coordination.

Other Requirements

• Travel (within and outside country).
• Work irregular hours, shifts rotation, weekends, holidays when necessary.
• Work as a resources in other strategic areas of business.
• Knowledge on cGMP's, Pharmaceutical Sciences (Dry product operations), Updated industry /regulatory trainings.
• English: written/spoken

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees.

The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800

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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