Associate Director – Parenteral Engineering, Operations Expansion

Initial Therapeutics, Inc.; Pleasant Prairie (WI); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Bonus potential

Comprehensive benefits package

401(k) and pension

Job summary

Lilly in the United States 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.

Actual compensation will depend on education, experience, and location.

Qualifications

• Requires 10+ years in pharmaceutical manufacturing with 5+ years in parenteral drug product manufacturing and aseptic processing.
• Demonstrated experience leading large-scale capital projects for manufacturing expansions or new facilities.
• Deep knowledge of cGMP, FDA/EMA guidelines for aseptic fill/finish and facility design.

Responsibilities

• Lead engineering design, development, and execution of parenteral expansion projects from concept to qualification.
• Oversee procurement, installation, and validation of aseptic lines, lyophilizers, isolators, and utilities.
• Collaborate with Manufacturing, Quality, Regulatory, and PM to define scope and timelines.
• Drive process improvements to enhance efficiency, reduce costs, and improve product quality.
• Mentor junior engineers and present updates to senior leadership.

Skills

Leadership

Project management

Communication

Analytical skills

Problem-solving

Travel readiness

Education

Bachelor's degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, or related

Master's degree preferred

Tools

Parenteral equipment

Aseptic processing equipment

Quality/regulatory knowledge

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.

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.

Job 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.

Basic Requirements:

• Bachelor's degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, or a related scientific discipline. Master's degree preferred.
• 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.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400.

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.