Associate Process Engineer - Dry External Manufacturing

Eli Lilly and Company • Carolina, IN

7d • Hybrid

About The Position

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. This role involves developing and sustaining process knowledge, direct and indirect interaction with contract manufacturers (CMs) and Original Equipment Manufacturers (OEMs) to ensure reliable supply, FUME assessment, participation in equipment specification and qualification, assessing HSE and PSM elements, and engaging in developing capabilities with new technologies. The role also includes establishing and sustaining process monitoring, and adherence to Lilly's policies.

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).
• 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.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• International travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. Travel is typically in the range of 15% to 25% annually, depending on the needs of the process(es).

Responsibilities

• 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 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.
• Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.
• Support and peer review root cause analysis around FUME and operational incidents.
• Peer review documentation of learning points, technical studies, and incident investigations.
• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).
• Enable the development and maintenance of process knowledge infrastructure such as key models, report history, lab models, and literature.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Review and track key process engineering metrics.
• Identify systemic issues affecting production and reliable supply from CMs
• Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations.
• Perform reviews of incident documentation for technical accuracy.
• Review and approve documentation and engineering decisions.
• Support development and technical analysis for on-going continuous improvement activities.
• Review and identify cost reduction opportunities, as well as process capacities and bottlenecks.
• Assist in prioritization of opportunities with respect to overall business objectives.
• Work with the CMs to ensure the application of statistical thinking and methods to understand process variability and capability.
• Perform and promote optimization of unit operation cycle time, loading, and yield performance.
• Engage with late phase development and Engineering Technical Center resources to ensure staying contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations).
• Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CMs.
• Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose.
• Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short- and long-term needs.
• Serve as the liaison for Dry -EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at the relevant contract manufacturing sites.
• Leverage internal Lilly experts in HSE and PSM to ensure appropriate risk reduction at CMs.
• Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable.
• Maintain key HSE and PSM metrics for review within DPN EM.
• Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of DPN EM contract manufacturing sites. These include but are not limited to: Financial Responsibility and Reporting (FRAP); Lilly Red Book; Lilly contract manufacturing standards; Lilly engineering standards, and Lilly Quality policies and best practices.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level