Engineer-Primary Container Closure

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
January 16 2019
Ref
47369BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.

The Delivery, Device and Connected Solutions (DDCS) Container Closure Engineer is a key role supporting DDCS's mission to “Simplifying Patients Lives”. This role functions in a Development setting and is focused on developing primary container closure systems, such as prefilled syringes, cartridges and other novel container systems. Parenteral packaging engineers also identify and develop new packaging technologies (materials, methods, and equipment) for Lilly products. Key customers of the parenteral packaging engineer include CMC, Manufacturing, and Regulatory. This individual will also interact with design partners and engineering firms as well as key suppliers providing the container closure components.
  • Serves as key technical resource in design, development and qualification of parenteral packaging components including but not limited to prefilled syringes, cartridges and other novel container closure systems for new drug products
  • Works closely with Formulation scientists, Analytical Development scientists, Device engineers, and Device and Drug Product Manufacturing colleagues in developing combination drug delivery devices for parenteral drug products
  • Provides deep technical advice and guidance for container closure systems and their associated combination product devices
  • Develop innovative and commercially implementable solutions to design problems that arise for the packaging components
  • Authors and review technical protocols, reports, and regulatory submissions
  • 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
  • Technology transfer to Manufacturing and due diligence inquiry
  • Demonstrated scientific, engineering, and applied cGMP skills
  • Outstanding oral and written communication skills, including technical report writing and regulatory document development
  • Problem solving and decision making skills
  • Fundamental knowledge of risk analysis and risk analysis tools
  • May represent Department or Company in interactions with internal and external committees or regulators, presentations, publications or other professional activities
  • Coaches and mentors others
  • Takes initiatives to expand on assignments and pursue novel ideas relevant to continuous improvement of existing and novel parenteral container closure systems
  • Enhances Lilly's competitive advantage through development of proprietary knowledge or by procurement of patents

Company Overview
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 39,000 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.

Basic Qualifications
  • BS in engineering with 10+ year of work experience or MS in Engineering with 7+ years of work experience.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • Previous pharmaceutical and/or medical device design experience in parenteral drug delivery systems
  • Strong understanding of combination product regulatory requirements and risk management systems is preferred
  • Experience with container closure system development for sterile products
  • Knowledge of relevant material characteristics
  • Knowledge of fundamental statistical concepts with the ability to apply them to process design, experimental design and process and design optimization
  • Experience with the drug development process
  • Fundamental knowledge of cGMP/laboratory compliance requirements
  • Leadership experience and influence skills
  • Strong analytical skills including statistics, DOE, and experimental design.
  • Experience in experimental/laboratory setup and documentation skills
Must be comfortable with hands on testing and assembly of prototypes

Additional Information
  • Estimated travel: up to 30% both domestic and international
  • Lilly Technology Center-North
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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