Associate Director - Process Engineering & Maintenance/Calibration

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

Organization Overview:

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description: 

This position is responsible for establishing and maintaining systems to ensure the reliable operation, maintenance and qualified state of process equipment, through management of a team of process engineers and technically skilled maintenance and calibration technicians.  Ensures that the process equipment is in control, compliant and capable of meeting plant production needs, while also driving continuous improvement efforts. This position is responsible for serving as subject matter expert in one or more disciplines and providing technical and leadership guidance to the engineering and maintenance teams, while also understanding the business impact and drivers outside of their own business area. 

Key Objectives/Deliverables: 

Manage for Results /Strategic Planning: 

Manage Process Engineering and Maintenance/Calibration support for Commercial Manufacturing Operations:

• Manage team of process engineers providing Front Line process engineering support.
• Manage team of maintenance technicians providing Front Line maintenance support.
• Ensure calibration requirements are maintained for all required equipment and systems via oversight of internal and external resources.
• Ensure appropriate technical support for all existing manufacturing processes including, Preparation/Sterilization, Formulation, Filling, Inspection, etc.
• Makes decisions guided by engineering standards and policies, procedures and business plan that impact the ability of the Process Engineers to meet performance objectives.
• Provide Functional Leadership to Process Team engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
• Support and peer review root cause analysis around equipment and operational events, support complex change controls, investigations. 
• Lead Complex investigations and have strong Root Cause analysis capability Ensure continuous improvement mindset for process and operational improvements Apply statistical thinking and methods to understand process variability and capability and drive improvements.
• Support regulatory inspections
• Provide oversight to team members on process equipment to ensure clear understanding of equipment flow, process flow and critical process requirements across all process steps on site.
• Establish control systems to monitor, trend and verify equipment performance and downtime.  Identify and Optimize unit operation cycle time, loading, yield performance, etc.
• Support or lead troubleshooting efforts to resolve equipment and operational problems, and ensure formal problem-solving techniques are appropriately utilized.
• Lead the process safety agenda for the process equipment
• Understand and ensure compliance with engineering standards, and environment health & safety requirements.
• Develop, review and approve technical documentations such as SOPs, Batch Records, Investigations, etc.
• Present and attend various Governance teams to represent process engineering
• Support commissioning and qualification activities

Leadership

• This position involves direct management of front-line process engineering, maintenance and calibration team members
• Provide leadership, training, development and support of process engineering, maintenance, and calibration team members.
• Engage and promote use of internal and external networks to help deliver sound technical decisions. 
• Promote use of first principals with engineering staff, and drive engineering solutions for problems.
• Monitor and ensure compliance with training requirements

Basic Requirements:

• Bachelor of Science in Engineering discipline.

Additional Preferences: 

• 7+ years industrial experience in cGMP environment preferred.
• Knowledge of/experience with pharmaceutical processes and equipment such as autoclaves, parts washers, formulation systems, filtration systems, filling systems, isolators, vision inspection systems, etc.
• Strong leadership skills
• Strong written and oral communication skills
• Self-directed personality, with ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
• Ability to resolve conflict, and promote good decision making among team members
• Experience with various root cause analysis tools/techniques

Other Information:  

• Travel not required. 
• Associate Director Required to be on call, as applicable. 
• Shift work may apply. 

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.

#WeAreLilly