BioSpace
Sr. Principal Process Engineer - Oligonucleotides
BioSpace, Houston, Texas, United States, 77246
Overview
Sr. Principal Process Engineer - Oligonucleotides. Lilly is building an advanced manufacturing facility for API molecules, including new modalities. This role provides technical leadership for production operations in oligonucleotide API supply, mentoring process engineers, sustaining process knowledge, optimizing processes and equipment, and overseeing qualification and capability of engineering systems and assets. During the project delivery and startup phase (expected 2029–2030), the role is 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 Seniority level
Mid-Senior level Employment type
Full-time 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is to be determined. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program, including a 401(k), medical, dental, vision, life insurance, flexible benefits, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs.
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Sr. Principal Process Engineer - Oligonucleotides. Lilly is building an advanced manufacturing facility for API molecules, including new modalities. This role provides technical leadership for production operations in oligonucleotide API supply, mentoring process engineers, sustaining process knowledge, optimizing processes and equipment, and overseeing qualification and capability of engineering systems and assets. During the project delivery and startup phase (expected 2029–2030), the role is 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 Seniority level
Mid-Senior level Employment type
Full-time 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is to be determined. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program, including a 401(k), medical, dental, vision, life insurance, flexible benefits, and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs.
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