Sr. Principal Associate - QA Clinical Trial Packaging Engineer

About the Role

Provides quality assurance oversight and technical support for Lilly’s external packaging operations (Collaboration Partners, or CP) within the Clinical Trial (CT) space. This role partners with CPs and cross-functional teams to ensure external packaging processes, systems, and documentation comply with cGMP requirements and Lilly Quality Standards. The position requires a quality mindset, strong follow-through, and effective collaboration to proactively identify and resolve quality issues at external sites.

Responsibilities

• Execute quality oversight of CP packaging operations by reviewing and approving quality records — including 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 the impact of proposed changes 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 Deviation Review Boards (DRBs) and Change Review Boards (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 areas of oversight.
• 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 and functions, applying learnings to drive practical improvements, supporting new CT product launches, acquisitions, and post-approval changes, and actively participating in audits, self-assessments, and regulatory inspections.

Requirements

• Bachelor’s degree in engineering (Packaging, Chemical, Mechanical, Industrial, or Materials Science) or a related scientific discipline; equivalent R&D experience in the pharmaceutical or medical device industry may substitute.
• 5+ years of experience in pharmaceutical or medical device manufacturing, packaging, or quality assurance in a cGMP environment.
• Proficiency with Microsoft Office; experience with QMS/eQMS systems (e.g., GDD, SAP) preferred; excellent technical writing skills required.

Skills

• Previous experience with pharmaceutical packaging systems, container closure systems, or secondary packaging development in a cGMP or CP environment.
• Prior work and understanding of blinding strategies and randomization as related to materials management in a pharmaceutical or device context.
• Proven ability to conduct root cause analysis, support deviation investigations, and manage CAPAs using structured problem-solving tools (e.g., FMEA, Casual Factor).
• Proficient in quality systems and tools including SAP, TrackWise (QMS), and eQMS platforms used in external manufacturing environments.
• Previous experience supporting regulatory inspections or CP audits and maintaining processes in a state of inspection readiness.
• Proven ability to collaborate effectively across cross-functional and external partner teams, communicate clearly, and follow through on commitments in a fast-paced, regulated environment.
• Prior work applying Operational Excellence or Lean manufacturing principles to drive continuous improvement within a quality or external manufacturing function.
• Proven ability to leverage AI tools and digital technologies to enhance quality workflows, accelerate documentation, support data analysis, and improve efficiency across quality assurance activities.

Additional Information

Location: Indianapolis, IN. Up to 20% domestic and international travel required to support CP site visits, audits, and technical operations activities. Standard Monday–Friday business hours; flexibility required to support CP schedules and off-hours critical issues as needed.

Pay

The anticipated wage for this position is $65,250 - $169,400. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits and flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).