Associate Director – Parenteral Engineering, Operations Expansion

Eli Lilly and Company • Pleasant Prairie, WI

5d • Onsite

About The Position

Eli Lilly and Company is seeking an Associate Director – Parenteral Engineering, Operations Expansion to lead the engineering and technical aspects of parenteral manufacturing expansion projects. This role will drive the design, implementation, and optimization of new and upgraded parenteral facilities, ensuring compliance with cGMP regulations and Lilly’s quality standards.

Requirements

• Bachelor's degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific discipline.
• Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years specifically in parenteral drug product manufacturing and aseptic processing.
• Demonstrated experience leading large-scale capital projects for manufacturing expansions or new facility builds within the pharmaceutical industry.
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and industry standards related to aseptic manufacturing, sterile product fill/finish, and facility design.
• Expertise in the design, qualification, and operation of parenteral manufacturing equipment (e.g., vial filling lines, pre-filled syringe lines, lyophilizers, isolators, cleanrooms, WFI/pure steam systems).
• Proven ability to manage complex projects, budgets, and schedules in a fast-paced environment.
• Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders.
• Strong analytical and problem-solving abilities.
• Experience with process optimization and lean manufacturing principles in a pharmaceutical context.
• Ability to travel domestically and internationally as required for project needs.

Nice To Haves

• Master's degree preferred.

Responsibilities

• Lead and manage the engineering design, development, and execution of parenteral manufacturing expansion projects, from conceptual design through commissioning and qualification.
• Oversee the selection, procurement, installation, and validation of new parenteral manufacturing equipment and systems, including aseptic filling lines, lyophilizers, isolators, and associated utilities.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory, and Project Management to define project scope, technical requirements, and deliverable timelines.
• Develop and implement engineering strategies to optimize manufacturing processes, improve efficiency, reduce costs, and enhance product quality for parenteral products.
• Ensure all engineering activities comply with internal Lilly standards, industry best practices, and applicable regulatory requirements (e.g., FDA, EMA).
• Manage external engineering firms, vendors, and contractors, ensuring adherence to project specifications, budget, and schedule.
• Conduct technical risk assessments and develop mitigation strategies for complex engineering challenges in a sterile manufacturing environment.
• Provide technical expertise and mentorship to junior engineers and project team members.
• Prepare and present project updates, technical reports, and proposals to senior leadership.
• Drive continuous improvement initiatives in parenteral engineering and operations.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager