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Sr. Principal Process Engineer - Molecule

Job in Houston, Harris County, Texas, 77246, USA
Listing for: BioSpace
Full Time position
Listed on 2025-12-25
Job specializations:
  • Engineering
    Process Engineer, Chemical Engineer, Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Position: Sr. Principal Process Engineer - Small Molecule

Sr. Principal Process Engineer - Small Molecule

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.

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. Key responsibilities include mentoring process engineers, sustaining process knowledge, supporting equipment and process optimization, and managing engineering systems and assets.

During the project delivery and startup phase (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 support full‑scale manufacturing.

Key Deliverables
  • 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 essential process knowledge (e.g., material/energy balances, kinetics, design basis)
  • Maintain and support process safety foundations and hazard review activities
  • Ensure equipment qualification aligns with intended use and remains valid after changes or maintenance
  • Integrate modeling and simulation to improve 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
  • Guide development of user requirements, design reviews, and verification plans
  • Advise on return‑to‑service protocols following equipment interventions
Basic Qualifications
  • Bachelor’s Degree in Process, Chemical, Biochemical Engineering or related STEM discipline
  • 5+ years of experience in API Manufacturing Unit Operations
Additional Preferences
  • Experience with API chemical synthesis and biotech unit operations, including chromatography
  • Understanding of GMP production environments
  • Strong technical foundation in Chemical Engineering
  • Skilled in analytical thinking and problem‑solving
  • Able to work independently and collaboratively within cross‑functional teams
  • Capable of coaching others to build technical expertise
  • Creative in identifying improvements and proactive in driving implementation
  • Experienced in mentoring through technical processes
  • Flexible and adaptable to meet 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 (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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