Sr. Principal Process Engineer - Oligonucleotides
Eli Lilly and Company
Full-time
Remote friendly (Houston, TX)
United States
Operations
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Role Summary
Sr. Principal Process Engineer – Oligonucleotides provides technical leadership for production operations, mentoring engineers, sustaining process knowledge, and overseeing process and equipment optimization within an oligonucleotide API context. The role involved startup and early operations as part of a GMP manufacturing site build, with a focus on building the organization, processes, and culture to enable 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
Qualifications
- Required: Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline
- Required: 5+ years of experience in API Manufacturing Unit Operations
Additional Qualifications
- 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