Associate Process Engineer – Dry External Manufacturing

Role Overview

• The Dry Products Process Engineer role provides 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.
• Developing and sustaining process knowledge 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 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.

Requirements

• Bachelor of Science degree in Mechanical or Chemical Engineering, or another engineering discipline with extensive manufacturing experience.
• 5 years of work experience in a manufacturing/process engineering related role
• Technical knowledge of Dry 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.
• 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
• Experience in typical unit operations for Dry Products Manufacturing (such as Spray Dry, Granulation, Tablet Press, Encapsulation and Coating
• 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).

Benefits

• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and 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)