Job Overview
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We are seeking a seasoned process engineer to spearhead technical leadership and expertise with contract manufacturers, ensuring reliable supply and commercialization of medicines.
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The successful candidate will develop and sustain process knowledge to execute product, process, and operational control strategies at multiple contract manufacturers.
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* Direct Interaction: Collaborate closely with contract manufacturer personnel to ensure reliable supply through effective execution of operational control strategies.
* FUME Assessment: Conduct thorough risk assessments to understand the impact on operational control strategies.
* Equipment Specification: Participate in equipment specification, procurement, and qualification processes with internal or contract manufacturer resources.
* HSE and PSM Elements: Work with internal and contract manufacturer resources to assess health, safety, and environmental elements that impact Lilly products.
* Technology Development: Engage with internal and external resources to develop capabilities with new or evolving technologies that may impact portfolio delivery.
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Key Requirements
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* Bachelor of Science in Chemical Engineering or another relevant engineering discipline with extensive GMP manufacturing experience.
* 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 process improvement.
* Ability to function as a technical leader within a team.
* Ability to manage and prioritize competing priorities and communicate effectively with varied audiences.
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Preferred Qualifications
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* Experience in Small Molecule API manufacturing or Peptide Synthesis/Purification.
* Ability to develop and implement innovative approaches to problems.
* Process Hazard Analysis experience.
* Root cause analysis and systematic problem solving experience.
* Strong computer skills (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office).
* Ability to model an operation/process and reflect it in a model.
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Work Environment
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A normal schedule is Monday–Friday, 8 hours/day. Teleconferences may occur outside these hours due to time zones of contract manufacturers. International travel may be required (roughly 15%–25% annually). Must complete assigned training curriculum. Tasks may require entering manufacturing and laboratory areas and wearing PPE.