Sr. Principal Process Engineer - Oligonucleotides

Reposted 15 Days Ago
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Houston, TX
In-Office
65K-167K
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Principal Process Engineer leads production operations, mentors engineers, optimizes processes, manages equipment qualification, and supports GMP systems during site startup.
Summary Generated by Built In

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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 Overview

The 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

Basic Qualifications

  • Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline 
  • 5+ years of experience in API Manufacturing Unit Operations 

Additional Preferences

  • 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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.


Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$ - $

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Top Skills

Chromatography
Gmp Support
Modeling And Simulation
Statistical Methods
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The Company
HQ: Indianapolis, IN
39,451 Employees
Year Founded: 1876

What We Do

Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment.

For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

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