Associate Director – Quality Engineer
Company: Eli Lilly and Company
Location: Houston
Posted on: January 20, 2026
|
|
|
Job Description:
At Lilly, we unite caring with discovery to make life better for
people around the world. We are a global healthcare leader
headquartered in Indianapolis, Indiana. Our employees around the
world work to discover and bring life-changing medicines to those
who need them, improve the understanding and management of disease,
and give back to our communities through philanthropy and
volunteerism. We give our best effort to our work, and we put
people first. We’re looking for people who are determined to make
life better for people around the world. Position Title: Associate
Director – Quality Engineer Position Type: Full-time Job Level:
R5-R6 Location: Houston, Texas Job Function: Quality Position Brand
Description: Associate Director – Quality Engineer is responsible
for providing technical guidance and leadership to the FUME
Operations and Facilities Management regarding the quality
standards employed to maintain and improve site operations. The
area of focus is facility, utility, maintenance, and equipment
(FUME) systems for oligonucleotide and small molecule processes.
Key Objectives/Deliverables: 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 QA. 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 QA 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. Basic Requirements: BS in Engineering or a
science-related field or equivalent experience. Minimum of 8 years
of relevant experience required. Additional Preferences: Experience
in API manufacturing, QA or Engineering. Must have hands-on
experience with oligonucleotide and small molecule processes.
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 QA, QC, Manufacturing, Engineering, Tech Services or
Regulatory Affairs. Education Requirements: BS in Engineering or
science-related field or equivalent experience. Other Information:
Tasks require entering manufacturing and laboratory areas which
require wearing appropriate PPE. The job specification is intended
to provide a general overview of the job requirements at the time
it was prepared. The job requirements of any position may change
over time and may include additional responsibilities not
specifically described in the job specification. As always, you
should consult with your supervision regarding your actual job
responsibilities and any related duties that may be required for
the position. Lilly is dedicated to helping individuals with
disabilities to actively engage in the workforce, ensuring equal
opportunities when vying for positions. If you require
accommodation to submit a resume for a position at Lilly, please
complete the accommodation request form (
https://careers.lilly.com/us/en/workplace-accommodation ) for
further assistance. Please note this is for individuals to request
an accommodation as part of the application process and any other
correspondence will not receive a response. Lilly is proud to be an
EEO Employer and does not discriminate on the basis of age, race,
color, religion, gender identity, sex, gender expression, sexual
orientation, genetic information, ancestry, national origin,
protected veteran status, disability, or any other legally
protected status. Our employee resource groups (ERGs) offer strong
support networks for their members and are open to all employees.
Our current groups include: Africa, Middle East, Central Asia
Network, Black Employees at Lilly, Chinese Culture Network,
Japanese International Leadership Network (JILN), Lilly India
Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ
Allies), Veterans Leadership Network (VLN), Women’s Initiative for
Leading at Lilly (WILL), enAble (for people with disabilities).
Learn more about all of our groups. Actual compensation will depend
on a candidate’s education, experience, skills, and geographic
location. The anticipated wage for this position is $115,500 -
$169,400 Full-time equivalent employees also will be eligible for a
company bonus (depending, in part, on company and individual
performance). In addition, Lilly offers a comprehensive benefit
program to eligible employees, including 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; and
well-being benefits (e.g., employee assistance program, fitness
benefits, and employee clubs and activities).Lilly reserves the
right to amend, modify, or terminate its compensation and benefit
programs in its sole discretion and Lilly’s compensation practices
and guidelines will apply regarding the details of any promotion or
transfer of Lilly employees. WeAreLilly
Keywords: Eli Lilly and Company, League City , Associate Director – Quality Engineer, Science, Research & Development , Houston, Texas