Eli Lilly and Company · 2 days ago
QA Engineer, Foundry
Lebanon, IN
Full-time
Onsite
Mid Level
$63K/yr - $163K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicine. The Lilly Medicine Foundry QA Engineer is responsible for ensuring compliance with quality systems and cGMP in a new manufacturing facility, providing technical guidance and oversight in various operations and processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations
Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements
Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts
Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.)
Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites
Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA)
Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately
Ensure the Foundry is audit ready at all times and participate in internal/external inspections
Qualification
Required
Bachelor of Science Degree in Engineering or related field (e.g. biology, chemistry, computer science, etc. with a minimum of 3 years previous FUME engineering experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
Preferred
Demonstrated relevant experience in a cGMP facility
Prior experience in C&Q, CSQ, and/or CSV
Proficient with computer systems including Microsoft Office, electronic document management systems (EDMS), Kneat, Trackwise, Maximo, etc
Demonstrated solid judgment and initiative
Ability to organize and prioritize multiple tasks and to problem solve effectively
Ability to work under time pressure and exert good judgment in special situations
Must exhibit good teamwork, communication, and interpersonal skills sustained over time
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