Engineering Associate Director (AD) - Device Assembly

BioSpace; Pleasant Prairie (WI); On-site; USD 140,000 - 190,000; Full time

Job summary

Lilly Kenosha County site is modernizing with a state-of-the-art manufacturing expansion. The Engineering Associate Director (AD) – Device Assembly will staff, train and lead the engineering group supporting asset delivery, process development, commissioning, qualification and startup of the packaging lines within the site expansion project.

After startup, the AD will handle day-to-day engineering activities and plan for the 3–6 month horizon, coaching others in safety, quality, and continuous

Qualifications

• Bachelor's degree in engineering is required.
• At least 7 years of process engineering experience.
• Experience leading or coordinating cross-functional teams is preferred.

Responsibilities

• Lead front-line & SME engineering and maintenance teams.
• Coach and develop engineering staff in safety, quality, and continuous improvement.
• Represent engineering in capital projects and regulatory interactions.
• Lead or participate in root cause analysis and change controls.
• Support commissioning and qualification activities for packaging lines.

Skills

Staffing leadership

Engineering leadership

Process engineering

Education

Bachelor's degree in engineering

Tools

Control systems

Job description

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.

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 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