Overview
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 work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and support communities through philanthropy and volunteerism. We are looking for people who are determined to make life better for people around the world.
Position Description
Senior / Principal Process Engineer - APIEM [ Synthetic Peptide Synthesis and Purification / Small Molecule ] reports to the Associate Director - Engineering API EM and provides technical leadership and expertise with API EM contract manufacturers (CMs) to ensure reliable supply and commercialization of medicines with safety first and quality always.
Responsibilities
* Develop and sustain process knowledge to execute the appropriate product, process, and operational control strategy at multiple CMs.
* 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.
* Participate with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
* Collaborate with internal and CM resources to assess HSE and PSM elements of the CM that impact Lilly products.
* Engage with internal and external resources to develop capabilities with new or evolving technologies that may impact portfolio delivery.
* Adhere to Lilly Red Book expectations when interacting with API EM’s CMs.
Key Objectives / Deliverables
* Coach and Mentor Process Team Members
o Provide insight on unit operation control to members of the CM Joint Process Team (JPT).
o Champion statistical thinking and data usage to monitor process performance with CM members of the JPT.
o Support and peer review root cause analyses around FUME and operational incidents.
o Peer review documentation of learning points, technical studies, and incident investigations.
* Develop and Sustain Process Knowledge
o Identify process knowledge gaps affecting equipment and process capability.
o Develop or support capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).
o Maintain process knowledge infrastructure (models, report history, lab models, literature).
o Utilize optimization tools for process analysis and improvement studies.
o Review and track key process engineering metrics.
* Provide Process & Equipment Support
o Identify systemic issues affecting production and reliable supply from CMs.
o Lead or participate in root cause analysis and countermeasure development for safety, quality, or throughput incidents; review incident documentation for technical accuracy.
o Review and approve documentation and engineering decisions.
* Process Optimization & Continuous Improvement
o Support development and technical analysis for ongoing CI activities.
o Identify cost reduction opportunities, capacities, and bottlenecks.
o Prioritize opportunities aligned with overall business objectives.
o Work with CMs to apply statistical thinking to understand process variability and capability.
o Optimize unit operation cycle time, loading, and yield performance.
o Engage with late-phase development and Engineering Technical Center to stay current with key engineering disciplines and portfolio platforms (e.g., continuous manufacturing).
* Equipment Capability and Asset Management
o Establish methodology to ensure visibility of qualification status of key FUME systems at CMs.
o Review equipment and process system user requirements and qualification plans to ensure suitability.
o Act as customer representative for CM capital project reviews for short and long-term needs.
* Oversight of HSE and PSM
o Serve as liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) at contract manufacturing sites.
o Leverage Lilly HSE and PSM experts to ensure risk reduction at CMs.
o Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable.
o Maintain key HSE and PSM metrics for API EM review.
* Adherence to Business, Quality, and Financial Systems
o Understand and follow Lilly policies and procedures for interactions and oversight of API contract manufacturing sites, including FRAP, Lilly Red Book, contract manufacturing standards, engineering standards, and quality policies.
Qualifications
* Basic Requirements:
o 3 years of work experience in a GMP manufacturing / process engineering related role.
o Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
o Ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
o Ability to function as a technical leader within a team.
o Ability to manage and prioritize competing priorities and communicate effectively with varied audiences.
* Additional Preferences:
o Experience in Small Molecule API manufacturing or Peptide Synthesis/Purification.
o Ability to develop and implement innovative approaches to problems.
o Process Hazard Analysis experience.
o Root cause analysis and systematic problem solving experience.
o Strong computer skills (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office).
o Ability to model an operation/process and reflect it in a model.
Education
* Bachelor of Science in Chemical Engineering, or another engineering discipline with extensive GMP chemical manufacturing experience.
Other Information
* 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.
* No certifications required.
* Tasks may require entering manufacturing and laboratory areas and wearing PPE.
EOE Notice
Lilly is dedicated to helping individuals with disabilities participate in the workforce with equal opportunities. If accommodation is needed to submit a resume, please request accommodation at: https://careers.lilly.com/us/en/workplace-accommodation. This request is for accommodation as part of the application process and other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.
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