Sr. Principal Associate - QA Clinical Trial Packaging Engineer

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

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.
• 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:

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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