Senior QA Packaging Engineer, Clinical Trials CPs

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave

Job summary

Lilly in Indianapolis, IN is hiring a PR&D QA CT Packaging Engineer (R3–R4) to provide quality assurance oversight and technical support for external packaging operations (CP) within the Clinical Trial space. You will ensure compliance with cGMP and Lilly Quality Standards, review quality records, and support validation activities at CP sites.

The role requires a quality mindset, strong collaboration with CPs and cross-functional teams, and experience with QMS/eQMS systems.

Qualifications

• Bachelor’s degree in engineering (Packaging, Chemical, Mechanical, Industrial, or Materials Science) or related scientific discipline; equivalent R&D experience may substitute.
• 5+ years of experience in pharmaceutical or medical device manufacturing, packaging, or quality assurance in a cGMP environment.
• English language required; proficiency with Microsoft Office; experience with QMS/eQMS systems and strong technical writing skills.

Responsibilities

• Execute quality oversight of CP packaging operations by reviewing and approving quality records, change controls, deviations, CAPAs, equipment qualifications, and periodic reviews, ensuring compliance with Lilly Quality Standards, cGMP requirements, and on-time closure in the eQMS.
• Support qualification and validation activities at external CP packaging sites by assisting in the review of IQ/OQ/PQ protocols, packaging stability studies, and revalidation efforts triggered by process or equipment changes, and assessing impact on validated states.
• Participate in root cause investigations for CP packaging-related deviations and non-conformances, including quality impact assessments, peer review of event investigations, CAPA development and tracking, and attendance at DRBs and CRBs as required.
• Provide QA oversight for material handling and control strategies at external CP sites, including nude/unlabeled drug product.
• Lead and/or actively participate in quality risk assessments pertaining to oversight areas as detailed in the position overview.
• Maintain current knowledge of applicable packaging regulations and compendial requirements.
• Demonstrate a quality mindset by proactively identifying quality issues at CP sites, collaborating across peers, driving practical improvements, supporting CT product launches, acquisitions, and post-approval changes, and participating in audits, self-assessments, and regulatory inspections.

Skills

Microsoft Office

Technical writing

Communication

Education

Bachelor’s degree in engineering or related scientific discipline

Tools

QMS/eQMS systems

SAP

GDD

Job description

Lilly in Indianapolis, IN is hiring a PR&D QA CT Packaging Engineer (R3–R4) to provide quality assurance oversight and technical support for external packaging operations (CP) within the Clinical Trial space. You will ensure compliance with cGMP and Lilly Quality Standards, review quality records, and support validation activities at CP sites.

The role requires a quality mindset, strong collaboration with CPs and cross-functional teams, and experience with QMS/eQMS systems.