Eli Lilly

Principal Process Engineer - API External Manufacturing (Large Molecule)

Eli Lilly • $66K — $171K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
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Job Overview by Ladders

Qualifications

  • Bachelor of Science in Chemical Engineering or related engineering field.
  • 5+ years of experience in chemical manufacturing.
  • 3+ years in manufacturing/process engineering for large molecules.
  • Technical leadership experience in a team environment.
  • Strong problem-solving capabilities with root cause analysis expertise.

Responsibilities

  • Lead technical initiatives to ensure reliable supply from contract manufacturers.
  • Assess and validate equipment suitability for process development.
  • Engage with teams for tech transfers and scale-up activities.
  • Review and optimize process performance through statistical methods.
  • Manage operational risks through FUME assessment and oversight.

Benefits

  • Comprehensive health coverage including medical, dental, and vision.
  • 401(k) and pension plan participation.
  • Generous vacation and paid time off.
  • Well-being programs including fitness and employee assistance.
  • Relocation assistance available if applicable.
Full Job Description
Position Brand Description:

The position of Principle Process Engineer - API EM Large Molecule reports to the API EM Engineering Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by:
  • Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs)
  • Assessment of the suitability of proposed equipment sets to ensure success of process validations
  • Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy
  • FUME assessment to ensure an understanding of risk presented to the operational control strategy
  • Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ
  • Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products
  • Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.
  • Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM's CMs.


Key Objectives/Deliverables:
Coach and Mentor Process Team Members
  • Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).
  • Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.
  • Support and peer review root cause analysis around FUME and operational incidents.
  • Peer review documentation of learning points, technical studies, and incident investigations.


Scale-Up & Tech Transfer
  • Lead/support tech transfers and scale-up from development through PV and commercial supply.
  • Translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness at CMs.
  • Support engineering runs and PV readiness through parameter optimization and performance trending.


Develop and Sustain Process Knowledge
  • Identify process knowledge gaps that impact equipment and process capability.
  • Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).
  • Enable the development and maintenance of process knowledge. infrastructure such as key models, report history, lab models, and literature.
  • Utilize optimization resources and tools for process analysis and process improvement studies.
  • Review and track key process engineering metrics.


Provide Process & Equipment Support:
  • Identify systemic issues affecting production and reliable supply from CMs
  • Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations. Perform reviews of incident documentation for technical accuracy.
  • Review and approve documentation and engineering decisions.


Process Optimization & Continuous Improvement:
  • Support development and technical analysis for on-going continuous improvement activities.
  • Review and identify cost reduction opportunities, as well as process capacities and bottlenecks. Assist in prioritization of opportunities with respect to overall business objectives.
  • Work with the CMs to ensure the application of statistical thinking and methods to understand process variability and capability.
  • Perform and promote optimization of unit operation cycle time, loading, and yield performance.
  • Engage with late phase development and Engineering Technical Center resources to ensure staying contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations).


Equipment Capability and Asset Management:
  • Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CMs.
  • Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose.
  • Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short- and long-term needs.


Oversight of HSE and PSM:
  • Serve as the liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at the relevant contract manufacturing sites.
  • Leverage internal Lilly experts in HSE and PSM to ensure appropriate risk reduction at CMs.
  • Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable.
  • Maintain key HSE and PSM metrics for review within API EM.


Adherence to Business, Quality, and Financial Systems:
  • Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites.


Basic Requirements:
  • Bachelor of Science degree in Chemical Engineering, or another engineering discipline with 5 plus years experience in chemical manufacturing.
  • 3+ years of work experience in a manufacturing/process engineering related role related to large molecules.
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Additional Preferences:
  • Experience in typical unit operations for Large Molecule API Manufacturing
  • Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
  • Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
  • Demonstrated ability to function in a team environment as a technical leader and as a member of teams.
  • Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
  • Develop and implement innovative approaches to problems
  • Process Hazard Analysis experience
  • Successful application of root cause analysis and systematic problem solving
  • Strong Computer skills in a variety of software packages ( e.g Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).
  • Visualize an operation/process and reflect it in a model.


Other Information:
  • This role is located onsite in Indianapolis, IN with the ability to work from home up to 4 days per month. Relocation assistance will be provided if applicable.
  • This role is not approved for 100% remote work
  • Travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the process(s).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600

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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