Senior / Principal Process Engineer - APIEM

Role Summary

Senior / Principal Process Engineer - APIEM. Provide technical leadership and expertise in conjunction with API EM contract manufacturers to ensure reliable supply and commercialization of medicines with safety and quality as priorities. Lead process knowledge development, equipment specification, QA/HSE alignment, and continuous improvement activities across contract manufacturing sites.

Responsibilities

• Developing and sustaining process knowledge to ensure execution of the appropriate product, process, and operational control strategy at multiple contract manufacturers.
• Direct and indirect interaction with CM personnel to ensure reliable supply via CM execution of the operational control strategy.
• FUME assessment to understand risk presented to the operational control strategy.
• Participation with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
• Participation with internal and CM resources to assess HSE and PSM elements impacting Lilly products.
• Engagement with internal and external resources to develop capabilities with new or evolving technologies affecting portfolio delivery.
• Adherence to Lilly Red Book standards when interacting with API EM‚Äôs CMs.
• Coach and mentor process team members, apply statistical thinking, and support root cause analysis around FUME and operational incidents.
• Peer review documentation of learning points, technical studies, and incident investigations.
• Identify process knowledge gaps, capture key process knowledge, and enable the development and maintenance of process knowledge infrastructure.
• Utilize optimization tools for process analysis and improvement; review and track key process engineering metrics.
• Identify systemic issues affecting production and reliable CM supply; lead or participate in root cause analysis and countermeasure development for safety, quality, or throughput incidents; review incident documentation for technical accuracy.
• Review and approve documentation and engineering decisions.
• Support ongoing continuous improvement activities; identify cost reduction opportunities, bottlenecks, and process capacities; prioritize opportunities aligned with business objectives.
• Collaborate with CM sites to apply statistical thinking to understand variability and capability; optimize unit operation cycle time, loading, and yield; engage with late-phase development and Engineering Technical Center resources to stay current with key engineering disciplines and portfolio platforms.
• Create methodologies to ensure visibility of qualification state for key FUME systems at CMs; review user requirements and qualification plans to ensure suitability of equipment and systems; act as customer representative for CM capital project requests.
• Serve as liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at CM sites; participate in HSE and PSM audits; maintain HSE and PSM metrics.
• Understand and follow Lilly policies related to interactions and oversight of CM sites, including financial and quality standards.

Qualifications

• Required: 3 years of work experience in a manufacturing/process engineering related role.
• Required: Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.
• Preferred: Experience in typical unit operations for API manufacturing; deep technical knowledge of API/Drug Substance manufacturing equipment and unit operations.
• Preferred: Ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
• Preferred: Ability to function in a team environment as a technical leader and team member; strong communication skills to various audiences.
• Preferred: Ability to manage and prioritize competing priorities; develop and implement innovative approaches to problems; Process Hazard Analysis experience; root cause analysis experience.
• Preferred: Strong computer skills (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office).
• Preferred: Ability to visualize operations/processes and reflect them in models.

Education

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

Additional Requirements

• Travel: OUS travel may be required to support process start-ups, troubleshooting, and commercial manufacturing; typically 15% to 25% annually.
• Work may require entering manufacturing and laboratory areas and wearing appropriate PPE.