Associate Director - Engineering - Packaging Operations

BioSpace; Pleasant Prairie (WI); On-site; USD 123,000 - 198,000; Full time

Benefits offered by this job

Comprehensive benefits program

401(k) and pension

Flexible benefits

Job summary

A leading pharmaceutical company in Pleasant Prairie is seeking an Engineering Associate Director for Packaging Operations. The role involves managing engineering teams, ensuring the success of packaging operations in a new site expansion, and adhering to stringent quality and safety standards. Candidates should have extensive experience in process engineering and leadership. This position offers a competitive salary range of $123,000 - $198,000, comprehensive benefits, and potential bonuses, promoting a robust work-life balance.

Qualifications

• Minimum of 7 years of process engineering experience.
• Strong experience in equipment optimization and troubleshooting.
• Experience with facility or area startups and equipment qualification.

Responsibilities

• Manage staffing, training, and leading engineering groups for packaging operations.
• Provide technical leadership to drive equipment reliability and continuous improvement.
• Ensure compliance with health and safety requirements.

Skills

Process engineering

Equipment optimization

Leadership

Troubleshooting

Regulatory knowledge

Education

Bachelor's degree in engineering

Tools

Manufacturing Execution Systems

Automated equipment

Job description

Overview

Lilly is entering an exciting period of growth and committed to delivering innovative medicines to patients worldwide. The company is investing over $3 billion to create a new state-of-the-art manufacturing site in Kenosha, Wisconsin, focusing on parenteral (injectable) medications, device assembly, and packaging operations. This is an opportunity to help build and operate a new site with high-tech equipment, integrated automated systems, and an emphasis on environmental responsibility.

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 work to discover and bring life-changing medicines to patients, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We put people first and seek colleagues determined to improve lives globally.

Position

The Engineering Associate Director (AD) – Packaging Operations is responsible for staffing, training, and leading the engineering group (process, automation, and maintenance) supporting asset delivery, process development, commissioning, qualification, validation, and startup of the packaging lines in the site expansion. After startup, the AD will support day-to-day engineering activities and plan for the 3–6 month horizon. The AD is expected to lead by example and coach others in safety, quality, engineering, optimization, and continuous improvement.

Key Objectives/Deliverables

Manage Engineering And Maintenance Support For Commercial Manufacturing Operations

• Manage a team of process and automation engineers and maintenance technicians providing Front Line support in areas including:
• 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), BMS, and Chambers (refrigerators, incubators, cold rooms, etc.)
• Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area
• Guide SMEs to coach Front Line Engineers and drive equipment reliability, uptime, continuous improvements, and capital delivery
• Ensure decisions align with engineering standards, policies, procedures, and business plans that affect team performance
• Provide Functional Leadership to engineering and maintenance through coaching in Change Management, Deviations/Investigations, Equipment and Process Improvements, and Process Controls
• Lead, support, and peer-review root cause analyses of equipment and operational events; support complex change controls and quality investigations with strong RCA focus
• Prioritize work to optimize equipment output and uptime with a continuous improvement mindset
• Apply statistical thinking and data analysis to understand variability and drive improvement
• Support regulatory inspections
• Use control systems to monitor and verify equipment performance and downtime; optimize unit operation cycle time, yield, recipes, etc.
• Assist or lead troubleshooting to resolve equipment/operation problems; on-call/off-hours support required
• Understand and ensure compliance with environment health & safety requirements
• Present and attend governance teams to represent engineering
• Represent the group as technical SMEs on capital projects, supporting/leading design, modifications, testing, qualifications, and associated documentation
• Support commissioning and qualification activities

Leadership

• Direct management of front-line and SME engineering and maintenance team members
• Provide leadership, training, development, coaching, and support to engineering team members
• Engage internal and external networks to help deliver sound technical decisions
• Promote first principles thinking and drive engineering solutions
• Monitor and ensure compliance with quality requirements (training, CAPA, deviations)

Basic Requirements

• Bachelor's degree in engineering
• At least 7 years of process engineering experience

Additional Preferences

• Previous management or cross-functional leadership experience
• Strong experience in equipment optimization, reliability, and troubleshooting
• Strong technical aptitude with ability to train and mentor others
• Solid understanding of regulatory requirements (FDA, EMEA, DEKRA, OSHA)
• Experience with highly automated equipment
• Experience with combination products, device assembly, pharmaceutical packaging, drug product formulation, and aseptic filling
• Experience with facility or area startups
• Experience with equipment qualification and process validation
• Experience with Manufacturing Execution Systems and electronic batch release
• Experience with ASRS or AGVs
• Experience with deviation and change management systems including Trackwise

Other Information

• Up to 20% travel during startup phase
• On-call availability as applicable

Shift work may apply.

Lilly is dedicated to helping individuals with disabilities to participate in the workforce and to providing equal opportunities. If accommodations are needed to submit a resume, please complete the accommodation request form. Lilly is an Equal Employment Opportunity (EEO) employer and does not discriminate on protected characteristics. Our employee resource groups (ERGs) offer support networks for members and are open to all employees. Compensation will depend on candidate education, experience, skills, and location. The anticipated wage for this position is $123,000 - $198,000. Full-time employees may be eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, leave benefits, and well-being programs. Lilly reserves the right to amend compensation and benefits at its discretion. #WeAreLilly