QA Packaging Lead for External CP in Clinical Trials

BioSpace; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly in Indianapolis, IN seeks a PR&D QA CT Packaging Engineer (R3–R4) to provide QA oversight for external CP packaging operations and to ensure compliance with Lilly quality standards and cGMP. You will support qualification/validation activities, investigations, CAPAs, and regulatory readiness.

This role requires a bachelor’s in engineering, 5+ years in pharma/medical device packaging or QA, and strong technical writing alongside MS Office and eQMS tools. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree in engineering or related scientific discipline; substitution allowed for R&D experience.
• 5+ years in pharmaceutical/medical device manufacturing, packaging, or QA in a cGMP environment.
• English required; strong written communication skills; proficient in MS Office and QA systems.

Responsibilities

• Oversight of CP packaging operations, reviewing quality records and CAPAs to ensure cGMP compliance.
• Assist in IQ/OQ/PQ protocols, packaging studies, and revalidation activities at external sites.
• Participate in root-cause investigations, CAPA development, and DRB/CRB activities as needed.
• Provide QA oversight for material handling and control strategies at CP sites, including nude/unlabeled drug products.
• Lead risk assessments and stay current with packaging regulations and compendial requirements.
• Demonstrate quality mindset, identify issues at CP sites, and drive practical improvements in launches and post‑approval changes.
• Support audits, self-assessments, and regulatory inspections.

Skills

Quality mindset

Collaborative skills

Technical writing

Education

Bachelor’s degree in engineering (Packaging, Chemical, Mechanical, Industrial, or Materials Science)

Tools

Microsoft Office

QMS/eQMS systems (GDD, SAP)

Job description

Lilly in Indianapolis, IN seeks a PR&D QA CT Packaging Engineer (R3–R4) to provide QA oversight for external CP packaging operations and to ensure compliance with Lilly quality standards and cGMP. You will support qualification/validation activities, investigations, CAPAs, and regulatory readiness.

This role requires a bachelor’s in engineering, 5+ years in pharma/medical device packaging or QA, and strong technical writing alongside MS Office and eQMS tools. Travel up to 20% may be required.