Senior QA CT Packaging Engineer for External Partners

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

Job summary

Lilly is seeking a PR&D QA CT Packaging Engineer (R3–R4) to provide quality assurance oversight for external CP packaging operations in the CT space. You will review quality records, participate in change controls, deviations, and CAPAs, and support IQ/OQ/PQ activities with external partners.

Ideal candidates have 5+ years in pharma/medical device QA or manufacturing, strong technical writing, and experience with QMS/eQMS systems.

Qualifications

• Bachelor's degree in engineering or related scientific field.
• 5+ years in pharma/medical device manufacturing, packaging, or QA in a cGMP environment.
• English proficiency required.
• Proficiency with Microsoft Office; experience with QMS/eQMS (e.g., SAP, TrackWise) preferred; strong technical writing skills.

Responsibilities

• Oversee CP packaging ops quality records, changes, deviations, CAPAs, equipment qualifications, and periodic reviews.
• Assist in IQ/OQ/PQ reviews and packaging validations; assess impact of changes on validated states.
• Participate in root cause investigations, CAPA development, and DRBs/CRBs attendance.
• Provide QA oversight for material handling and control strategies at CP sites.
• Maintain knowledge of packaging regs and compendial requirements; support audits and inspections.

Skills

Technical writing

Quality mindset

Cross-functional collaboration

Office software proficiency

Education

Bachelor's degree in Packaging/Engineering

Tools

SAP

TrackWise

eQMS platforms

Job description

Lilly is seeking a PR&D QA CT Packaging Engineer (R3–R4) to provide quality assurance oversight for external CP packaging operations in the CT space. You will review quality records, participate in change controls, deviations, and CAPAs, and support IQ/OQ/PQ activities with external partners.

Ideal candidates have 5+ years in pharma/medical device QA or manufacturing, strong technical writing, and experience with QMS/eQMS systems.