Quality Assurance Engineer

Eli Lilly and Company • Lebanon, IN

1d • Onsite

About The Position

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and bringing life-changing medicines to people worldwide. The company is constructing an advanced manufacturing facility for API molecules in Lebanon, IN (Lilly Lebanon API), representing its largest investment in manufacturing capacity. This facility will produce APIs for current and future products, including new modalities. This role offers a unique opportunity to join the startup team for this greenfield site, contributing to the development of processes and the facility for successful GMP manufacturing operations. The Quality Engineer will provide technical guidance and leadership to the LP1 site, focusing on quality standards for utilities, bulk distributed materials (BDMs), and facilities/equipment qualification, aiming to maintain and improve site operations.

Requirements

• Bachelors Degree in Engineering or science related field.
• 1+ years in pharmaceutical industry
• 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.

Nice To Haves

• Previous experience in pharmaceutical industry
• Previous experience in QA, TS/MS QC or Engineering
• Prior work with cGMPs or external regulations
• Previous experience with root cause investigations
• Effective problem-solving and analytical skills to resolve operational issues.

Responsibilities

• Provide direct quality oversight to LP1 manufacturing and laboratory operations and assist others in interpretation of regulatory and corporate requirements.
• Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives.
• Work with cross functional teams to implement QA objectives.
• Prepare for and participate in internal and external regulatory inspections.
• Maintain and improve facility, utility, maintenance and equipment (FUME) quality systems.

Benefits

• eligibility for a company bonus (depending, in part, on company and individual performance)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees