Eli Lilly and Company · 6 days ago
Principal Process Engineer – Filling
US, Pleasant Prairie WI
Full-time
Onsite
Senior Level, Lead/Staff
$117K/yr - $172K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. The Principal Process Engineer – Filling plays a critical role as a technical leader and Subject Matter Expert, ensuring the safe and efficient operation of manufacturing processes in compliance with regulatory standards.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Use data to track performance and guide decisions
Utilize optimization resources and tools for process analysis and process improvement studies
Ensure systems remain in a qualified state and are appropriate for use
Ensure maintenance and calibration activities are established and periodically reviewed for trends – generate action plans for improvements, if needed
Ensure maintenance and calibration activities are established and periodically reviewed
Apply statistical thinking and methods to understand process variability and capability, and establish/drive improvements, accordingly
Assist with and review documents related to key learning points, technical analyses, and investigations of incidents
Guide engineers in process expertise, problem-solving, critical thinking, project management, design and excellence in execution. Review and approve documentation/decisions requiring “responsible” engineer level of authority
Lead or participate in root cause analysis and countermeasure development and implementation of major safety, quality, or throughput incident investigations. Performs review of incident documentation for technical accuracy
Identify process bottlenecks and assist in prioritization of opportunities with respect to overall business objectives
Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness
Develop project scopes for both short- and long-term capital projects, serving as user representative or project manager when needed
Sponsor and manage technology transfers, and improvement initiatives from concept through execution
Lead or assist with root cause analysis and countermeasure implementation for major safety, quality, or throughput incidents. Review incident documentation for technical accuracy
Support development and technical analysis for long term large-scale initiatives such as productivity improvements, GMP remediation, and safety risk mitigation
Review and track key process engineering metrics
Coach junior engineers, promote standardization of technical procedures, and foster alignment with global engineering principles
Support development of training and training material for cross-functional teams including operations, QA, MSAT
Qualification
Required
Bachelor's degree in engineering
10+ years senior engineering experience in a parenteral manufacturing site
5+ years of aseptic filling operation experience
Solid understanding of basic requirements of regulatory agencies
Product Tech transfer experience
Equipment trouble shooting experience
Previous facility or area start up experience
Prior experience working effectively with a cross functional group including network and/or global functions
Excellent interpersonal, written, and oral communication skills
Strong technical aptitude and ability to train and mentor others
Ability to handle multiple competing priorities
Preferred
Previous experience for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
Previous experience with highly automated equipment
Previous experience with Optima PFS lines
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release
Previous experience with CMMS systems
Previous experience with deviation and change management systems including Trackwise
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
Represents job field similar to this job
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
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2026-01-25
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2026-01-23
Company data provided by crunchbase