Principal Process Engineer - API External Manufacturing (Large Molecule)

BioSpace; Indianapolis (IN); Hybrid; USD 66,000 - 171,600; Full time

Benefits offered by this job

Relocation assistance

Job summary

BioSpace is seeking a Principle Process Engineer for API EM Large Molecule to provide technical leadership with contract manufacturers, ensuring safe, compliant supply of medicines.

You will scale-up, transfer processes from development to PV and commercial supply, develop process knowledge, and mentor team members while overseeing HSE/PSM at CM sites.

Additionally, you will drive continuous improvement, execute process optimization, and ensure adherence to company policies and quality systems.

Qualifications

• Bachelor of Science in Chemical Engineering or related field; 5+ years in chemical manufacturing.
• 3+ years in manufacturing/process engineering related to large molecules.
• Authorized to work in the United States full-time; Lilly will not provide sponsorship.
• Experience leading technical transfers, scale-up, and CM collaborations is preferred.

Responsibilities

• Provide technical leadership with CM personnel to ensure reliable supply and quality.
• Lead/process knowledge development and equipment qualification activities.
• Support tech transfers from development to PV and commercial supply.
• Mentor JPT and champion data-driven process improvements.
• Lead root cause analyses for safety, quality, or throughput incidents.
• Review and approve documentation and engineering decisions.

Skills

Chemical manufacturing experience

Large molecule process engineering

Technical leadership

Education

B.S. in Chemical Engineering or related field

Tools

Batch Plus

JMP

Visio

Aspen

Dynochem

OSI PI

MS Office

Job description

Position Brand Description

Position of Principle Process Engineer - API EM Large Molecule reports to the API EM Engineering Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always.

• 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)
• Assessment of the suitability of proposed equipment sets to ensure success of process validations
• Direct and Indirect interaction with CM personnel 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 or CM 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.
• Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.

Key Objectives/Deliverables

Coach and Mentor Process Team Members

• 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.

Scale‑Up & Tech Transfer

• Lead/support tech transfers and scale‑up from development through PV and commercial supply.
• Translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness at CMs.
• Support engineering runs and PV readiness through parameter optimization and performance trending.

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 And Asset Management

• 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 API 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 API EM.

Adherence To Business, Quality, And Financial Systems

• Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites.

Basic Requirements

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with 5 plus years experience in chemical manufacturing.
• 3+ years of work experience in a manufacturing/process engineering related role related to large molecules.
• 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.

Additional Preferences

• Experience in typical unit operations for Large Molecule API Manufacturing
• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
• Demonstrated ability to apply fundamental chemical 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.
• Develop and implement innovative approaches to problems
• Process Hazard Analysis experience
• 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.

Other Information

• This role is located onsite in Indianapolis, IN with the ability to work from home up to 4 days per month. Relocation assistance will be provided if applicable.
• This role is not approved for 100% remote work.
• Travel may routinely be required to support process start‑ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the process(s).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. 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.

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.