QA Engineer, - Lilly Medicine Foundry

Role Summary

The QA Engineer at Lilly Medicine Foundry is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within the Foundry, ensuring compliance with quality systems and cGMP. This role supports drug substance manufacturing, central utilities, warehouse, and laboratory facilities, as part of a team building and qualifying a new green-field manufacturing site.

Responsibilities

• Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
• Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
• Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets, including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
• Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites.
• Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support investigations to ensure proper root cause analysis (RCA) and CAPA.
• Escalate and/or initiate notification to management for departures of critical nature and ensure issues are addressed appropriately.
• Ensure the Foundry is audit ready at all times and participate in internal/external inspections.

Qualifications

• Required: Bachelor of Science Degree in Engineering or related field (e.g., biology, chemistry, computer science) with a minimum of 3 years of FUME engineering experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
• Preferred: Demonstrated relevant experience in a cGMP facility.
• Preferred: Prior experience in C&Q, CSQ, and/or CSV.
• Preferred: Proficient with computer systems including Microsoft Office, electronic document management systems (EDMS), Kneat, Trackwise, Maximo, etc.
• Preferred: Demonstrated solid judgment and initiative.
• Preferred: Ability to organize and prioritize multiple tasks and problem-solve effectively.
• Preferred: Ability to work under time pressure and exercise good judgment in special situations.
• Preferred: Effective teamwork, communication, and interpersonal skills sustained over time.

Education

• Bachelor of Science Degree in Engineering or a related field (e.g., biology, chemistry, computer science) with relevant FUME/cGMP experience.