Senior / Principal Process Engineer – APIEM
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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. Lilly is dedicated to helping individuals with disabilities and ensuring equal opportunities for all applicants. If you require accommodation to submit a resume, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation.
Position Brand Description
The position of Senior / Principal Process Engineer – APIEM [Synthetic Peptide Synthesis and Purification / Small Molecule] reports to the Associate Director – Engineering API EM. The engineer provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel to ensure reliable supply and commercialization of medicines with safety first and quality always by:
* Developing and sustaining process knowledge to ensure execution of the appropriate product, process, and operational control strategy at Contract Manufacturers (CMs).
* Direct and indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
* FUME assessment to understand risk presented to the operational control strategy.
* Participating with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
* Assessing the HSE and PSM elements of the CM that impact Lilly products.
* Engaging with internal and external resources to develop capabilities with new or evolving technologies that may impact delivery of portfolio assets.
* Adhering to the expectations of the Lilly Red Book when interacting with API EM’s CMs.
Key Objectives/Deliverables
* Coach and mentor Process Team Members through unit operation control experience, statistical thinking, and data-driven engineering decisions.
* Support peer review of root cause analysis around FUME and operational incidents.
* Document learning points, technical studies, and incident investigations.
Develop and Sustain Process Knowledge
* Identify process knowledge gaps that impact equipment and process capability.
* Capture key process knowledge including material balances, kinetics, chemistry, modeling, and equipment design basis.
* Maintain infrastructure such as key models, lab models, and literature.
* Utilize optimization resources and tools for 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 for major safety, quality, or throughput incidents.
* Review and approve documentation and engineering decisions.
Process Optimization & Continuous Improvement
* Support development and analysis for ongoing continuous improvement activities.
* Identify cost reduction opportunities, process capacities, and bottlenecks.
* Prioritize opportunities with respect to overall business objectives.
* Apply statistical thinking to understand process variability and capability.
* Optimize unit operation cycle time, loading, and yield performance.
Equipment Capability and Asset Management
* Ensure visibility of qualification status of key FUME systems at CMs.
* Review equipment and process system user requirements and qualification plans.
* Act as customer representative for review of CM capital project requests.
Oversight of HSE and PSM
* Serve as liaison for API EM and Global HSE on health, safety, environmental, and process safety management oversight at contract sites.
* Leverage internal experts to reduce risk at CMs.
* Participate in HSE and PSM audits of contract manufacturing sites.
* Maintain HSE and PSM metrics for review within API EM.
Adherence to Business, Quality, and Financial Systems
* Follow Lilly policies and procedures for oversight of API contract manufacturing sites, including FRAP, Lilly Red Book, contract manufacturing standards, engineering standards, and quality policies.
Basic Requirements
* 3+ years of work experience in a GMP manufacturing/process engineering related role.
* Deep technical knowledge of API / drug substance manufacturing equipment and unit operations.
* Ability to apply fundamental chemical engineering principles to process understanding, problem solving, and improvement.
* Technical leadership ability and teamwork skills.
* Strong prioritization and communication skills, both verbal and written.
Additional Preferences
* Experience in unit operations for Small Molecule API manufacturing or peptide synthesis/purification.
* Innovative problem‑solving and root‑cause analysis skills.
* Process hazard analysis experience.
* Computer skills: Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite.
* Capability to visualize operations/processes and reflect them in models.
Education Requirements
* Bachelor of Science in Chemical Engineering or another engineering discipline with extensive GMP chemical manufacturing experience.
Other Information
* Normal schedule Monday‑Friday, 8 hours/day; teleconferences may occur outside these hours. International travel 15‑25% annually.
* Must complete assigned training curriculum.
* No certifications required.
* Tasks require entering manufacturing and laboratory areas and wearing appropriate PPE.
Equal Employment Opportunity Statement
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly does 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.
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