Eli Lilly

Associate Director - Parenteral Engineering, Operations Expansion

Eli Lilly • $123K — $180K *
Pleasant Prairie, WI 53158In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field; Master's preferred.
  • 10+ years in pharmaceutical manufacturing, 5+ years in parenteral drug product manufacturing.
  • Proven experience leading large-scale capital projects for manufacturing.
  • Strong knowledge of cGMP regulations and FDA/EMA guidelines relevant to aseptic manufacturing.
  • Expertise in the operation and design of parenteral manufacturing equipment.
  • Skilled in managing complex projects, budgets, and schedules.
  • Excellent teamwork and communication skills.

Responsibilities

  • Lead and manage parenteral manufacturing expansion projects from design to qualification.
  • Oversee procurement and validation of aseptic manufacturing equipment.
  • Collaborate with various teams to define project scope and timelines.
  • Develop strategies for optimizing manufacturing processes and product quality.
  • Ensure compliance with internal standards and regulatory requirements.
  • Manage relationships with external engineering firms and vendors.
  • Conduct technical risk assessments and implement mitigation strategies.

Benefits

  • Participation in a company-sponsored 401(k) and pension plan.
  • Comprehensive medical, dental, vision, and prescription benefits.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and death benefits provided.
  • Generous vacation and leave of absence benefits.
  • Well-being programs including an employee assistance program and fitness benefits.
Full Job Description
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.

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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