Sr. Principal Associate - QA Clinical Trial Packaging Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Job Position Overview:

The PR&D QA CT Packaging Engineer (R3–R4) provides quality assurance oversight and technical support for Lilly’s external packaging operations (referred to as Collaboration Partners (CP) within the Clinical Trial (CT) space. Working under general direction and growing in independence, this individual partners with CPs and cross-functional teams to ensure that external packaging processes, systems, and documentation comply with cGMP requirements and Lilly Quality Standards. The role requires a quality mindset, strong follow-through, and effective collaboration across peers and functions 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 as detailed within position overview.
• Maintain current knowledge of applicable packaging regulations and compendial requirements.
• Demonstrate a quality mindset in all endeavors 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.

Basic Qualifications:

• Education Level: 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.
• Experience: 5+ years of experience in pharmaceutical or medical device manufacturing, packaging, or quality assurance in a cGMP environment.
• Licenses: N/A
• Language Requirements: English (required).
• Required Skills Testing: Proficiency with Microsoft Office required; experience with QMS/eQMS systems (e.g.,GDD, SAP) preferred; excellent technical writing skills required.

Additional Skills / Preferences:

• 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.