Principal Engineer - Dry EM

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.

Responsibilities

The Dry Products Process Engineer role provides the technical leadership and support in conjunction with Dry Products External Manufacturing contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by :

Developing and sustaining process knowledge in order to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs)

Direct and Indirect interaction with CM personnel and Original Equipment Manufacturer (OEM) to ensure reliable supply via the CM execution of the operational control strategy

FUME assessment to ensure an understanding of risk presented to the operational control strategy

Participation with internal, CM, and OEM resources in the equipment specification, procurement, and IQ / OQ / PQ

Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products

Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.

Engage in establishing and sustaining process monitoring for operations on key process equipment, partner with IT / Automation to integrate technology

Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.

Basic Requirements

3 years of work experience in a manufacturing / process engineering related role

Technical knowledge of DPN manufacturing equipment and unit operations.

Demonstrated ability to apply engineering principles to process understanding, problem solving, and process improvement.

Demonstrated ability to function in a team environment as a technical leader and as a member of teams.

Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.

Education :

Bachelor of Science degree in Mechanical or Chemical Engineering, or another engineering discipline with extensive manufacturing experience.

Skills :

Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner

A thorough understanding of cGMPs and drug product manufacturing

Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment

Good communication skills, especially attention to detail in written procedures and protocol development

Capability to work in a virtual and complex environment

Willingness to travel

Appreciation for cultural diversity and inclusive leadership

Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools & principles

Additional Skills / Preferences

Experience in typical unit operations for Dry Products Manufacturing

Develop and implement innovative approaches to problems

Successful application of root cause analysis and systematic problem solving

Strong Computer skills in a variety of software packages ( e.g Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).

Visualize an operation / process and reflect it in a model.

Ability to work independently as well as part of a team.

Ability to prioritize activities.

Good judgment and flexibility.

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 (

• 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.

Lillydoes 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.

WeAreLilly

Explore Location Close the popup

Apply Now Save job

#J-18808-Ljbffr