Eli Lilly and Company · 1 month ago
Senior / Principal Process Engineer - APIEM
US, Indianapolis IN
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Senior / Principal Process Engineer to provide technical leadership and expertise in the reliable supply and commercialization of medicines, ensuring safety and quality by developing process knowledge and supporting contract manufacturers.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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)
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
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
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
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
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)
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
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
Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites. These include but are not limited to: Financial Responsibility and Reporting (FRAP); Lilly Red Book; Lilly contract manufacturing standards; Lilly engineering standards, and Lilly Quality policies and best practices
Qualification
Required
3 years of work experience in a manufacturing/process engineering related role
Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience
Preferred
Experience in typical unit operations for API Manufacturing 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
Benefits
Company bonus (depending, in part, on company and individual performance)
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-12
2026-01-12
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