QA Engineer

Eli Lilly - Lebanon, PA

Full-time - Mid Level

Lebanon, PA

10,001+ employees

Chemical Manufacturing

About the position

The QA Engineer at Lilly is responsible for providing technical guidance and leadership regarding quality standards to maintain and improve site operations at the new manufacturing facility in Lebanon, IN. This role focuses on utilities, bulk distributed materials, and facilities/equipment qualification, ensuring compliance with GMP manufacturing practices. The successful candidate will play a key role in the startup of this greenfield manufacturing site, contributing to the development of the organization and its culture.

Responsibilities

• Provide direct quality oversight of production, engineering, automation, and laboratory operations.
• Review and approve documents including procedures, change control proposals, deviations, and equipment/system qualification/validation.
• Provide coaching, feedback, and mentoring to engineering and QA teams regarding quality systems execution.
• Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.
• Conduct gap assessments of global requirements and ensure implementation of governing standards.
• Participate in and/or lead self-inspection activities and regulatory inspections.
• Assist business partners in interpreting regulatory and corporate requirements.

Requirements

• BS in Engineering or science-related field
• GMP manufacturing knowledge and/or experience
• 2+ years manufacturing experience
• Must be mobile to Puerto Rico

Nice-to-haves

• Thorough technical understanding of quality systems and regulatory requirements
• Demonstrated coaching and mentoring skills
• Experience in root cause analysis
• Demonstrated application of statistical skills
• Experience in API or finished product manufacturing, QA or Engineering
• Experience with system and equipment qualifications
• Knowledge of cGMPs and quality systems
• Demonstrated strong written and verbal communications skills
• Strong attention to detail
• Excellent interpersonal skills and networking skills
• Ability to organize and prioritize multiple tasks
• Demonstrated flexibility when faced with changing priorities
• Proficiency with computer system applications and process automation systems

Benefits

• Employee resource groups (ERGs) for support and networking
• Equal opportunity employer
• Accommodations for individuals with disabilities