Engineering Associate Director (AD) - Device Assembly
Initial Therapeutics, Inc., Pleasant Prairie, WI, United States
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.
Overview Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 billion to create a new state‑of‑the‑art manufacturing site in Kenosha, Wisconsin. The brand‑new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once‑in‑a‑lifetime opportunity to help build and operate a new site. The Lilly Kenosha County site will be built using the latest high‑tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
Position Brand Description The Engineering Associate Director (AD)- Device Assembly is responsible for the staffing, training, and leadership of the engineering group (both process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification and validation and startup of the packaging lines in the site expansion project. After startup, the Engineering AD will be responsible for supporting the day‑to‑day engineering activities as well as planning for the 3‑6‑month horizon. The Engineering AD is expected to lead by example and provide coaching to others in the areas of safety, quality, engineering, optimization and continuous improvement.
Key Objectives/Deliverables Manage for Results /Strategic Planning
Manage Engineering and Maintenance support for Commercial Manufacturing Operations
Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas
Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
Device Assembly
Packaging Operations
Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e. Refrigerators, Incubators, Cold Rooms, etc.)
Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area
Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives
Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives
Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus
Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization
Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements
Support regulatory inspections
Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem‑solving techniques are appropriately utilized. On call/off hours support required.
Understand and ensure compliance with environment health & safety requirements
Present and attend various Governance teams to represent engineering
Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation
Support commissioning and qualification activities
Leadership
This position involves direct management of front‑line & SME engineering and maintenance team members
Provide leadership, training, development, coaching and support of engineering team members
Engage and promote use of internal and external networks and partnerships 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 quality requirements. (trainings, CAPA, deviations)
Basic Requirements
Bachelor's degree in engineering
At least 7 years process engineering experience
Additional Preferences
Previous management or leadership experience including leading or working effectively with a cross functional group
Strong experience in equipment optimization, reliability and troubleshooting
Strong technical aptitude and ability to train and mentor others
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
Previous experience with deviation and change management systems including Trackwise
Other Information
Up to 20% travel and more can be expected during the startup phase
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 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
$123,000 - $198,000
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
#J-18808-Ljbffr
Overview Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 billion to create a new state‑of‑the‑art manufacturing site in Kenosha, Wisconsin. The brand‑new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once‑in‑a‑lifetime opportunity to help build and operate a new site. The Lilly Kenosha County site will be built using the latest high‑tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
Position Brand Description The Engineering Associate Director (AD)- Device Assembly is responsible for the staffing, training, and leadership of the engineering group (both process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification and validation and startup of the packaging lines in the site expansion project. After startup, the Engineering AD will be responsible for supporting the day‑to‑day engineering activities as well as planning for the 3‑6‑month horizon. The Engineering AD is expected to lead by example and provide coaching to others in the areas of safety, quality, engineering, optimization and continuous improvement.
Key Objectives/Deliverables Manage for Results /Strategic Planning
Manage Engineering and Maintenance support for Commercial Manufacturing Operations
Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas
Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
Device Assembly
Packaging Operations
Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e. Refrigerators, Incubators, Cold Rooms, etc.)
Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area
Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives
Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives
Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus
Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization
Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements
Support regulatory inspections
Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem‑solving techniques are appropriately utilized. On call/off hours support required.
Understand and ensure compliance with environment health & safety requirements
Present and attend various Governance teams to represent engineering
Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation
Support commissioning and qualification activities
Leadership
This position involves direct management of front‑line & SME engineering and maintenance team members
Provide leadership, training, development, coaching and support of engineering team members
Engage and promote use of internal and external networks and partnerships 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 quality requirements. (trainings, CAPA, deviations)
Basic Requirements
Bachelor's degree in engineering
At least 7 years process engineering experience
Additional Preferences
Previous management or leadership experience including leading or working effectively with a cross functional group
Strong experience in equipment optimization, reliability and troubleshooting
Strong technical aptitude and ability to train and mentor others
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
Previous experience with deviation and change management systems including Trackwise
Other Information
Up to 20% travel and more can be expected during the startup phase
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 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
$123,000 - $198,000
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
#J-18808-Ljbffr