Parenteral Filling Process Engineer
About The Position
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Delivery, Devices, and Connected Solutions (DDCS) organization within Eli Lilly's Product Research & Development is a diverse team responsible for discovering, designing, and developing patient-centric drug delivery solutions across various modalities. DDCS drives drug delivery innovation across early and late development to meet the needs of an expanding portfolio. The Parenteral Packaging team within DDCS is a specialized capability focused on the design, development, and commercialization of filling processes and container closure systems for parenteral drug products, including vials, prefilled syringes, and cartridges. This team partners across innovation and commercialization verticals to enable clinical supply, technology transfer, and commercial manufacturing readiness. This role is for a Parenteral Filling Process Engineer to serve as a key technical contributor within DDCS's Parenteral Packaging horizontal. This position provides advanced technical expertise in filling process development and lyophilization process engineering for parenteral packaging and Lilly's combination products. The candidate will drive the development of filling processes and associated equipment across the full development lifecycle, from clinical to commercial, while collaborating closely with CMC, device design, manufacturing, and quality partners across the DDCS matrix.
Requirements
- Bachelor's degree in Chemical, Biochemical, Mechanical Engineering, or related field
- 8+ years of experience in pharmaceutical parenteral (solution or lyophilized sterile drug product) formulation process or fill-finish processes
- Advanced level knowledge in parenteral filling process development and handling of sterile single-use components for various CCS in aseptic filling applications.
- Experience with combination products, drug delivery devices, and container closure systems.
- Experience working effectively with cross-functional groups and external partners.
- Strong technical communication and documentation skills
- Cross-functional collaboration within a complex pharmaceutical R&D matrix
- Regulatory and quality mindset in GMP/GxP, ICH, and/or aseptic manufacturing environments
Nice To Haves
- Master's degree in Chemical, Biochemical, Mechanical Engineering, or related field with 5+ years of experience as listed above, OR PhD with 2+ years of experience as listed above
- Previous vendor and partner management experience with CDMOs and OEMs is a strong preference
- Previous pharmaceutical primary packaging selection, assessment, and qualification experience.
- Familiarity with Quality by Design (QbD) and ICH guidelines.
- Solid understanding of regulatory agency requirements (FDA, EMA, ICH).
- Prior knowledge of lyophilization process development
- Experience with using multiple filling process technologies (ie time-pressure, rotary piston, peristaltic pumps)
- Technology scouting and innovation orientation
- Self-motivated and capable of delivering results with minimal oversight
Responsibilities
- Lead parenteral filling process development projects for container closure systems (vials, prefilled syringes, cartridges) throughout Lilly's drug product development cycle.
- Perform filling process development and machinability assessment across hand-filling lab instruments, semi-automated pilot lines, automated flexible lines, and high-speed commercial filling lines.
- Develop deep understanding of equipment flow charts, critical process parameters, and process/equipment operation instructions.
- Partner with Lilly SMEs, CDMOs, and OEMs to develop de-risked and viable filling equipment and process pathways for clinical and commercial manufacturing.
- Work closely with parenteral packaging engineers to prepare drug/placebo-filled samples for container closure suitability assessment, system qualification, and regulatory filing.
- Support pharmaceutical primary packaging selection, assessment, and qualification.
- Bring expertise to device-drug combination product compatibility and filling process integration.
- Collaborate with Lilly internal cross-functional SMEs including Biological Formulation & Process Development, Clinical Trial Operations, DDCS Device Design & Development, Commercial Engineering, Procurement, and Quality.
- Support due diligence on selection of CDMOs and fill-finish equipment manufacturers (OEMs) for clinical trials.
- Manage equipment vendors including project execution and on-site testing.
- Work with TS/MS SMEs and statisticians to develop filling control strategy.
- Support technology transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
- Apply Quality by Design (QbD) principles; develop ICH-aligned control strategies and process validation frameworks.
- Draft and review technical protocols and reports for parenteral drug product process development.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP policies and procedures.
- Support team, department, and corporate initiatives through pertinent technical input.
- Drive exploration of state-of-the-art technologies to advance effective business solutions, improve product quality, and accelerate development timelines.
- Ensure a safe working environment by following safety rules and actively participating in safety activities (audits, JSAs, hazard reviews).
- Mentor and coach junior engineers on fill and finish process development.
- Enhance Lilly's professional image through presentations, external conferences, and publications.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
