Sr. Principal Associate - QA Clinical Trial Packaging Engineer
Eli Lilly and Company
August 17, 2026
On-site
Indianapolis, IN
Operations
Job Position Overview:
PR&D QA CT Packaging Engineer (R3–R4) provides quality assurance oversight and technical support for Lilly’s external packaging operations (Collaboration Partners/CPs) in Clinical Trials. Ensures external packaging processes, systems, and documentation comply with cGMP requirements and Lilly Quality Standards; partners with CPs and cross-functional teams to identify and resolve quality issues.
Responsibilities:
- Review/approve quality records (change controls, deviations, CAPAs, equipment qualifications, periodic reviews) and ensure compliance and on-time eQMS closure.
- Support IQ/OQ/PQ protocol, packaging stability studies, and revalidation due to process/equipment changes; assess impact on validated states.
- Participate in root cause investigations for deviations/non-conformances; perform quality impact assessments; peer review event investigations; develop/track CAPAs; attend DRBs/CRBs as required.
- Provide QA oversight for material handling/control strategies (including nude/unlabeled drug product).
- Lead/participate in quality risk assessments.
- Maintain knowledge of packaging regulations/compendial requirements.
- Proactively identify quality issues; support improvements, CT product launches, acquisitions, and post-approval changes; participate in audits/assessments/regulatory inspections.
Basic Qualifications:
- BS in engineering (Packaging/Chemical/Mechanical/Industrial/Materials) or related science; equivalent pharma/med device R&D experience may substitute.
- 5+ years cGMP pharma/med device manufacturing, packaging, or QA experience.
- English required.
- Microsoft Office proficiency; excellent technical writing.
Additional/Preferred Skills:
- Packaging/container closure/secondary packaging experience in cGMP/CP environment.
- Knowledge of blinding/randomization for materials management.
- Root cause analysis and CAPA management tools (e.g., FMEA, Casual Factor).
- Experience with SAP, TrackWise, and eQMS platforms.
- Regulatory inspection/CP audit experience; inspection readiness.
- Strong cross-functional/external partner collaboration.
- Operational Excellence/Lean experience.
- Ability to leverage AI/digital tools to improve quality workflows.
Additional Information:
- Location: Indianapolis, IN.
- Travel: up to 20% domestic/international.
- Hours: standard Mon–Fri; flexibility for CP schedules/off-hours.
Benefits (company-sponsored, as stated):
- Eligibility for bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, certain time off/leave, and well-being benefits (e.g., employee assistance, fitness, clubs).
PR&D QA CT Packaging Engineer (R3–R4) provides quality assurance oversight and technical support for Lilly’s external packaging operations (Collaboration Partners/CPs) in Clinical Trials. Ensures external packaging processes, systems, and documentation comply with cGMP requirements and Lilly Quality Standards; partners with CPs and cross-functional teams to identify and resolve quality issues.
Responsibilities:
- Review/approve quality records (change controls, deviations, CAPAs, equipment qualifications, periodic reviews) and ensure compliance and on-time eQMS closure.
- Support IQ/OQ/PQ protocol, packaging stability studies, and revalidation due to process/equipment changes; assess impact on validated states.
- Participate in root cause investigations for deviations/non-conformances; perform quality impact assessments; peer review event investigations; develop/track CAPAs; attend DRBs/CRBs as required.
- Provide QA oversight for material handling/control strategies (including nude/unlabeled drug product).
- Lead/participate in quality risk assessments.
- Maintain knowledge of packaging regulations/compendial requirements.
- Proactively identify quality issues; support improvements, CT product launches, acquisitions, and post-approval changes; participate in audits/assessments/regulatory inspections.
Basic Qualifications:
- BS in engineering (Packaging/Chemical/Mechanical/Industrial/Materials) or related science; equivalent pharma/med device R&D experience may substitute.
- 5+ years cGMP pharma/med device manufacturing, packaging, or QA experience.
- English required.
- Microsoft Office proficiency; excellent technical writing.
Additional/Preferred Skills:
- Packaging/container closure/secondary packaging experience in cGMP/CP environment.
- Knowledge of blinding/randomization for materials management.
- Root cause analysis and CAPA management tools (e.g., FMEA, Casual Factor).
- Experience with SAP, TrackWise, and eQMS platforms.
- Regulatory inspection/CP audit experience; inspection readiness.
- Strong cross-functional/external partner collaboration.
- Operational Excellence/Lean experience.
- Ability to leverage AI/digital tools to improve quality workflows.
Additional Information:
- Location: Indianapolis, IN.
- Travel: up to 20% domestic/international.
- Hours: standard Mon–Fri; flexibility for CP schedules/off-hours.
Benefits (company-sponsored, as stated):
- Eligibility for bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, certain time off/leave, and well-being benefits (e.g., employee assistance, fitness, clubs).