Senior Packaging Engineer-Delivery & Device Research and Development

Eli Lilly

(Indianapolis, Indiana)
Full Time
Job Posting Details
About Eli Lilly
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.
Responsibilities
* 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.
Ideal Candidate
* 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.

Questions

Answered by on
This question has not been answered
Answered by on

There are no answered questions, sign up or login to ask a question

Want to see jobs that are matched to you?

DreamHire recommends you jobs that fit your
skills, experiences, career goals, and more.