Associate Director - Quality Engineer

Engineer – FUMEKey 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 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.

• 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.

• 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.

• BS in Engineering or science‑related field or equivalent experience.

• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must support 24 hour/day operations.
• Qualified applicants must be authorized to work in the United States on a full‑time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400 Full‑time. 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 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.