Quality Assurance Engineer

Role Summary

The Quality Engineer provides technical guidance and leadership at the LP1 site to maintain and improve quality standards for utilities, bulk distributed materials (BDMs), and facilities/equipment qualification. This role supports manufacturing and laboratory operations and interfaces with cross-functional teams to implement QA objectives. The position is based at the Lilly Lebanon API site in Lebanon, IN and supports startup activities for GMP manufacturing operations.

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.

Qualifications

• Required: 1+ years in pharmaceutical industry.
• Required: 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.
• Preferred: Previous experience in pharmaceutical industry.
• Preferred: Previous experience in QA, TS/MS QC or Engineering.
• Preferred: Prior work with cGMPs or external regulations.
• Preferred: Previous experience with root cause investigations.

Education

• Bachelor's Degree in Engineering or science related field.

Skills

• Effective problem-solving and analytical skills to resolve operational issues.

Additional Requirements

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule.