Associate Process Engineer - Dry External Manufacturing

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 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 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.

Key Objectives/Deliverables:

• 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.

Develop and Sustain Process Knowledge

• 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.

Provide Process & Equipment Support

• 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.

Process Optimization & Continuous Improvement

• 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).

Equipment Capability, Asset Management, and Process Performance

• 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.

Oversight of HSE and PSM

• 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.

Adherence to Business, Quality, and Financial Systems

• 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.

Education:

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

Basic Requirements:

• 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.
• Language: English

Additional Information

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. 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).
• Person-In-Plant may be required for periods of time
• Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law.Marijuana is considered unauthorized by Lilly.

"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."

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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