Eli Lilly and Company · 1 day ago
Associate Director - Quality Engineer
Glen Allen, VA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$126K/yr - $205K/yr
8+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on improving the lives of people through innovative medicines. They are seeking an Associate Director - Quality Engineer to provide technical guidance and leadership regarding quality standards for operations, ensuring compliance and continuous improvement in quality systems.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide direct quality oversight of production, engineering, automation, and laboratory operations
Review and approve documents including, but not limited to, procedures, change control proposals, deviations, equipment/system qualification/validation, analytical methods, and computerized system validations as business FUME
Provide quality guidance and recommendations regarding manufacturing, materials, utilities, maintenance, and laboratory issues
Participate in aberrant data investigations (i.e., deviation investigations)
Conduct analytical data review including stability data
Disposition API Intermediates and raw materials, as appropriate
Provide coaching, feedback and mentoring to engineering and FUME as it relates to execution of quality systems
Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems
Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate
Conduct gap assessments of global requirements and ensure implementation of the governing standards
Participate in and/or lead, support self-inspection activities and regulatory inspections
Maintain and improve FUME quality systems
Assist business partners in the interpretation of regulatory and corporate requirements
Qualification
Required
BS in Engineering or a science-related field or equivalent experience
Must have hands-on experience with ADC (Antibody Drug Conjugate) processes
Minimum of 8 years of relevant experience in engineering or quality roles
Preferred
Experience in API or finished product manufacturing, FUME or Engineering
Experience with system and equipment qualifications
Demonstrated strong written and verbal communications skills
Strong attention to detail
Proficiency with computer system applications
Knowledge of cGMPs and quality systems
Understanding of statistical tools and analysis
Excellent interpersonal skills and networking skills
Ability to organize and prioritize multiple tasks
Previous experience in FUME, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs
Benefits
Company bonus
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
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
2026-01-13
GlobeNewswire
2026-01-13
Company data provided by crunchbase