Sr. Principal Process Engineer - Oligonucleotides
Listed on 2025-12-14
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Engineering
Process Engineer, Manufacturing Engineer, Chemical Engineer
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 currently constructing an advanced manufacturing facility for the production of API molecules. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Position OverviewThe Senior Principal Process Engineer provides technical leadership for production operations in small molecule or peptide manufacturing. Responsibilities include mentoring process engineers, sustaining process knowledge, supporting process and equipment optimization, managing equipment qualification and capability, and overseeing engineering systems and assets.
During the project delivery and startup phase (expected 2029–2030), the role will be dynamic and collaborative—focused on building the organization, implementing GMP-supporting systems and processes, and shaping site culture to enable successful full-scale manufacturing.
Responsibilities- Mentor process engineers in core engineering practices for oligonucleotide API supply
- Promote data-driven decision-making using statistical methods and first principles
- Support and review root cause analyses and technical documentation
- Identify and address process knowledge gaps affecting equipment and process performance
- Capture key process knowledge such as material and energy balances, kinetics, and design basis
- Maintain process safety foundations and support hazard reviews
- Ensure equipment qualification aligns with intended use and remains valid after changes or maintenance
- Integrate modeling and simulation to enhance process understanding and control
- Drive continuous improvement in equipment and processes as part of cross-functional teams
- Lead or support tech transfer of new processes and unit operations
- Oversee development of user requirements, design reviews, and verification plans
- Guide return-to-service protocols following equipment interventions
- Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
- 5+ years of experience in API Manufacturing Unit Operations
- Experience with API chemical synthesis, biotech operations, and chromatography
- Familiar with GMP production environments
- Strong foundation in chemical engineering and technical problem-solving
- Able to work independently and within cross-functional teams
- Skilled in coaching and mentoring for technical development
- Proactive in identifying and implementing improvements
- Flexible and responsive to evolving business needs
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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.
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