Eli Lilly and Company · 10 hours ago
Principal Process Engineer
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$64K/yr - $167K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Principal Process Engineer will provide technical oversight in the Device and Packaging Manufacturing division, ensuring quality and compliance in the production of life-saving medications.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Demonstrate a strong ownership for the equipment and packaging area you support by being flexible, proactive and involved. Serve as a responsible engineer for site process lines by possessing a deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines
Ensure the equipment is maintained in its validated state (AQM)
Approve the scope of qualifications and re-qualification monitoring activities
Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on the safety or quality integrity of the equipment or process
Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance
Identify and drive improvement opportunities
Support with complex sites investigation of key safety and production issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals
Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success
Use first principles and theoretical knowledge to define scientific approaches to support technical improvements. Utilize in depth understanding of materials, process, and equipment to improve process robustness, reduce variability, and provide improvements in operational uptime and effectiveness
Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share best practices, technical principles and meet manufacturing goals
Collaboratively integrate different disciplines such as quality, technical services, and operations on projects and process performance improvements
Mentor and provide coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. This may include coaching on first principles, change or deviation management and processing issue resolution
Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive
Willingness to openly share, to speak up and ensure others understand the risks when making business choices and decisions
Lead by example in building and driving a culture of safety first and quality always within the organization
Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary reports, etc
Qualification
Required
Bachelor's Degree in Engineering, Science or related field
5+ years' experience in pharmaceutical manufacturing or regulated industry
In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices
Preferred
Prior experience in packaging and/or dry/wet device assembling operations
Experience with asset design, delivery, and start up preferred
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions
Strong interpersonal and presentation skills with the ability to collaborate effectively across diverse teams and stakeholders
Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines
Demonstrated, strong analytical and problem-solving abilities
Variable travel of 0-50% plus could be expected based upon specific site and functional requirements
Benefits
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
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
2026-01-12
2026-01-12
Company data provided by crunchbase