QA Engineer, Foundry

Role Summary

The Lilly Medicine Foundry QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within the Foundry and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes supporting drug substance manufacturing, central utilities, warehouse, and laboratory facilities. This role is part of a team supporting the design, construction, and qualification at the Foundry as this new manufacturing site is built at a green field 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 the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
• Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately.
• Ensure the Foundry is audit ready at all times and participate in internal/external inspections.

Qualifications

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

Skills

• Quality systems and regulatory expectations interpretation
• Commissioning and Qualification (C&Q)
• Computer Systems Validation (CSV)
• Maintenance/Calibration program oversight
• Root cause analysis (RCA) and CAPA development
• Auditing and inspection readiness

Education

• Bachelor of Science Degree in Engineering or related field

Additional Requirements

• Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.