Eli Lilly and Company · 10 hours ago
Engineer – FUME & CSQ PRD Quality Assurance
Indianapolis, IN
Full-time
Hybrid
Mid, Senior Level
$65K/yr - $169K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking an Engineer for Quality Assurance with responsibilities including overseeing quality compliance for facility utilities and computer systems in product research and development, as well as providing technical guidance and leadership in various quality assurance processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Contribute Quality expertise from a FUME standpoint to ensure successful execution of capital projects at LTC-N (primarily focused on K360 pilot plant)
Collaborate with PRD CSQ QA representative(s) to effectively manage CSV workload, ensuring timely and comprehensive delivery of all CSQ work at LTC-N
Coach and mentor others in aspects of fundamental Quality Engineering and computer system validation support, including process knowledge, problem solving, project management, and documentation design
Provide consultation and interpretation of local procedure, Lilly and Global standards, and regulatory expectations
Review and approve applicable procedures to ensure compliance with Lilly Quality standards and regulatory requirements. Assess potential gaps between local procedures and Lilly and Global standards and facilitate remediation efforts
Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation (CSV) of GMP assets including review and approval of associated Engineering/GMP deliverables
Influence and oversee GMP drawings including review and approval of GMP drawings
Evaluate potential product quality impact for any GMP-related incident (Change Control and non-conformance), perform initial leveling, and support the investigations to ensure proper RCA and establishment of effective CAPA to prevent recurrence
Escalate/Notification to Management for departure of critical nature and assure issues are addressed appropriately
Perform Quality approvals of GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations
Ensure PR&D is audit ready at all times and participate in internal/external inspections
Qualification
Required
Bachelor's degree in biochemistry, engineering, pharmacy, or science-related field
At least 5 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
Previous experience as a FUME or CSV professional
Preferred
Strong knowledge of GMP, FUME processes, and Computer System Validation principles
Become/remain certified on CSV (Computer System Validation)
Excellent communication and documentation skills
Ability to work collaboratively in a fast-paced environment
Proficient in influencing complaint/deviation/change authors via both verbal and written feedback
Proven ability to envision and oversee implementation of continuous improvements
Previous QA experience
Benefits
Company bonus
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)
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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
Business Standard India
2026-01-14
2026-01-14
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2026-01-14
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