BioSpace
Sr. Principal Process Engineer - Small Molecule
BioSpace, Houston, Texas, United States, 77246
Overview
Sr. Principal Process Engineer - Small Molecule at BioSpace (Lilly). The Senior Principal Process Engineer provides technical leadership for production operations in small molecule or peptide manufacturing, 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 is dynamic and collaborative—focused on building the organization, implementing GMP-supporting systems and processes, and shaping site culture to support full-scale manufacturing. Lilly is constructing an advanced manufacturing facility for the production of API molecules to support current and future products, including new modalities. This is a unique opportunity to be part of the startup leadership team for a manufacturing site and help build the organization, facility and culture to enable GMP manufacturing operations. 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 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 Qualifications
Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline 5+ years of experience in API Manufacturing Unit Operations Preferred Background
Experience with API chemical synthesis and biotech unit operations, including chromatography Understanding of GMP production environments Strong technical foundation in Chemical Engineering Analytical thinking and problem-solving skills Ability to work independently and in cross-functional teams Experience mentoring others and driving improvements Flexible and adaptable to evolving business needs Equal Opportunity and Benefits
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodation requests for applying. Lilly is an EEO employer and does not discriminate on legally protected characteristics. Compensation will depend on education, experience, skills, and location; anticipated wage ranges will be provided during the hiring process. Full-time employees are eligible for a comprehensive benefits program including 401(k), pension, health benefits, flexible spending accounts, life insurance, time off, and well-being programs. Lilly reserves the right to amend compensation and benefits programs as needed. #WeAreLilly
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Sr. Principal Process Engineer - Small Molecule at BioSpace (Lilly). The Senior Principal Process Engineer provides technical leadership for production operations in small molecule or peptide manufacturing, 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 is dynamic and collaborative—focused on building the organization, implementing GMP-supporting systems and processes, and shaping site culture to support full-scale manufacturing. Lilly is constructing an advanced manufacturing facility for the production of API molecules to support current and future products, including new modalities. This is a unique opportunity to be part of the startup leadership team for a manufacturing site and help build the organization, facility and culture to enable GMP manufacturing operations. 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 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 Qualifications
Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable STEM discipline 5+ years of experience in API Manufacturing Unit Operations Preferred Background
Experience with API chemical synthesis and biotech unit operations, including chromatography Understanding of GMP production environments Strong technical foundation in Chemical Engineering Analytical thinking and problem-solving skills Ability to work independently and in cross-functional teams Experience mentoring others and driving improvements Flexible and adaptable to evolving business needs Equal Opportunity and Benefits
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides accommodation requests for applying. Lilly is an EEO employer and does not discriminate on legally protected characteristics. Compensation will depend on education, experience, skills, and location; anticipated wage ranges will be provided during the hiring process. Full-time employees are eligible for a comprehensive benefits program including 401(k), pension, health benefits, flexible spending accounts, life insurance, time off, and well-being programs. Lilly reserves the right to amend compensation and benefits programs as needed. #WeAreLilly
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