Senior Packaging Engineer-Delivery & Device Research and Development

Lilly is a global health care leader that unites caring with discovery to make life better for people around the world. For more than a century, we have stayed true to a core set of values—excellence, integrity, and respect for people—that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

• Evaluation or creation of finite element analysis, tolerance stacks, manufacturing processes and scale-up, moldflow analysis, DOE, FMEA's. Experience in DFx (manufacturing, reliability, assembly, ultrasonic welding parameters, gluing, and snap fits).
• Design Validation and Verification activities experience with the device
• quality system regulation.
• Coordinate device risk assessment and design control deliverables(including ensuring the completion of required phase documentation and phase closure)
• Conduct meetings and prepare design-specific project presentations and reports, in addition to publishing basic schedules and participating in project problem-solving
• Partner with manufacturing, contract developers and quality to ensure robust design, testing, and design control deliverables.
• Management updates: responsible to provide design-related opinions to support the integrity of device projects for internal senior management.
• writing technical reports, work instructions, change control documentation and development plans
• Expertise in general project management skills, and a familiarity with the major steps required in technical product development, especially in a regulated environment
• Lead development and qualification of packaging components and container closure systems for new drug products with an emphasis on prefilled syringes in support of the parenteral portfolio.
• Author, review, and approve technical reports and/or regulatory submissions.
• Direct scientists and engineers in appropriate design of experiments and interpretation of the data.
• Ensure reliable delivery of technically sound work products (e.g., regulatory modules, technical reports, qualification reports, development history reports, etc.).
• Present technical information on projects and technologies at meetings and seminars.
• Provide in-depth technical advice and guidance beyond department.
• May serve as a representative of the department or company for industry regulators.
• Represent the department or company in steering committees associated with drug development, internal or external to Lilly.
• Enhance Lilly’s professional image and competitive advantage by patents, presentations, publications and professional activities.
• Maintain close partnership with partner groups, including IDM, Clinical
• Trial Mfg/Pkg, Engineering Tech Center, Mfg Sites, and TS/MS.
• Participate in the corporate procurement strategy for packaging components.
• Actively participate on cross-functional teams to ensure alignment and effective running of the business.

• Basic Qualifications
• BS, MS or PhD in mechanical, materials, chemical or biomedical engineering or relevant scientific discipline
• 11+ (BS), 7+ (MS) or 3+ years (PhD) in Medical Device, Aeronautical, Automotive, Pharmaceutical or Consumer Product Design Experience
• Additional Skills/Preferences
• Previous pharmaceutical and/or medical device design experience.
• Strong understanding of medical device and/or pharmaceutical validation, regulatory requirements and risk management systems is preferred
• Materials science knowledge with experience in development and qualification of container closure and packaging systems (e.g. container integrity, extractables/leachables, tolerance stack-up, performance/mechanical attributes, packaging control strategy).
• Experience with container closure development for sterile products.
• Experience with the drug development process.
• Fundamental knowledge of cGMP/laboratory compliance requirements.
• Demonstrated scientific and engineering skills.
• Outstanding oral and written communication skills, including technical report writing.
• Leadership experience and influence skills
• Strong analytical skills including statistics, DOE, and experimental design.
• Strong technical writing skills required, as well as good verbal communication skills.
• Experience in experimental/laboratory setup and documentation skills
• Must be comfortable with hands on testing and assembly of prototypes.