Associate Director – Quality Engineer at Eli Lilly and Company

Houston, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

BS in Engineering or a science-related field or equivalent experience
Minimum of 8 years of relevant experience
Additional Preferences
Experience in API manufacturing, QA or Engineering
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

Responsibilities

Provide direct quality oversight of production, engineering, automation, and laboratory operations
Review and approve documents including 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

Skills

Quality Assurance

Change Control

Deviations

Equipment Qualification

System Validation

Analytical Methods

Computerized System Validation

Deviation Investigations

Stability Data Review

API Disposition

FUME Systems

GMP

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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