Associate Director - Quality Engineer
Eli Lilly and Company
4 months ago
On-site
Henrico, VA
$126,000 - $204,600 USD yearly
Operations
Position Brand Description
- The Engineer – FUME provides technical guidance and leadership to Richmond, Virginia API/Fill finish Operations and Richmond Facilities Management sites regarding the quality standards used to maintain and improve site operations (focus: utilities and bulk distributed materials (BDMs), with backup in facilities, systems, and equipment management).
Key Objectives/Deliverables
- Provide direct quality oversight of production, engineering, automation, and laboratory operations.
- Review and approve procedures, change control proposals, deviations, equipment/system qualification/validation, analytical methods, and computerized system validations as business FUME.
- Provide quality guidance and recommendations for manufacturing, materials, utilities, maintenance, and laboratory issues.
- Participate in aberrant data/deviation investigations.
- Conduct analytical data review, including stability data.
- Disposition API intermediates and raw materials, as appropriate.
- Coach, provide feedback, and mentor engineering and FUME on execution of quality systems.
- Maintain and improve 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.
- Conduct gap assessments of global requirements and ensure implementation of governing standards.
- Participate in and/or lead and support self-inspection and regulatory inspection activities.
- Assist business partners in interpreting regulatory and corporate requirements.
Basic Requirements
- BS in Engineering or a science-related field (or equivalent experience); hands-on ADC (Antibody Drug Conjugate) process experience required.
- Minimum 8 years relevant experience in engineering or quality roles.
Additional Preferences
- Experience in API or finished product manufacturing, FUME, or Engineering.
- Experience with system and equipment qualifications.
- Strong written and verbal communication skills.
- Strong attention to detail.
- Proficiency with computer system applications.
- Knowledge of cGMPs and quality systems.
- Understanding of statistical tools and analysis.
- Excellent interpersonal and networking skills.
- Ability to organize and prioritize multiple tasks.
- Previous experience in FUME, QC, Manufacturing, Engineering, Tech Services, or Regulatory Affairs.
Education Requirements
- BS in Engineering or science-related field (or equivalent experience).
Other Information
- No certifications required.
- Requires entering manufacturing and laboratory areas (PPE required).
- Must support 24 hour/day operations.
- The Engineer – FUME provides technical guidance and leadership to Richmond, Virginia API/Fill finish Operations and Richmond Facilities Management sites regarding the quality standards used to maintain and improve site operations (focus: utilities and bulk distributed materials (BDMs), with backup in facilities, systems, and equipment management).
Key Objectives/Deliverables
- Provide direct quality oversight of production, engineering, automation, and laboratory operations.
- Review and approve procedures, change control proposals, deviations, equipment/system qualification/validation, analytical methods, and computerized system validations as business FUME.
- Provide quality guidance and recommendations for manufacturing, materials, utilities, maintenance, and laboratory issues.
- Participate in aberrant data/deviation investigations.
- Conduct analytical data review, including stability data.
- Disposition API intermediates and raw materials, as appropriate.
- Coach, provide feedback, and mentor engineering and FUME on execution of quality systems.
- Maintain and improve 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.
- Conduct gap assessments of global requirements and ensure implementation of governing standards.
- Participate in and/or lead and support self-inspection and regulatory inspection activities.
- Assist business partners in interpreting regulatory and corporate requirements.
Basic Requirements
- BS in Engineering or a science-related field (or equivalent experience); hands-on ADC (Antibody Drug Conjugate) process experience required.
- Minimum 8 years relevant experience in engineering or quality roles.
Additional Preferences
- Experience in API or finished product manufacturing, FUME, or Engineering.
- Experience with system and equipment qualifications.
- Strong written and verbal communication skills.
- Strong attention to detail.
- Proficiency with computer system applications.
- Knowledge of cGMPs and quality systems.
- Understanding of statistical tools and analysis.
- Excellent interpersonal and networking skills.
- Ability to organize and prioritize multiple tasks.
- Previous experience in FUME, QC, Manufacturing, Engineering, Tech Services, or Regulatory Affairs.
Education Requirements
- BS in Engineering or science-related field (or equivalent experience).
Other Information
- No certifications required.
- Requires entering manufacturing and laboratory areas (PPE required).
- Must support 24 hour/day operations.