The Sr. Principal Engineer will be the technical subject matter expert in aseptic, biotherapeutic drug product compounding, accountable for overall E2E process engineering leadership
Job Summary
The Sr. Principal Engineer will be the technical subject matter expert in aseptic, biotherapeutic drug product compounding, accountable for overall E2E process engineering leadership.
Key responsibilities include developing and delivering equipment specifications, assessing vendor competency, leading detailed design, and ensuring compliance to regulatory standards.
This role requires extensive interaction with external partners and a strong understanding of cGMPs, EHS requirements, and industry trends for biotherapeutics.
Matching Summary
The Sr. Principal Engineer will be the technical subject matter expert in aseptic, biotherapeutic drug product compounding, accountable for overall E2E process engineering leadership.
Skills & Requirements
Must-have
Aseptic biotherapeutic drug product compounding
Single-use technology design
Stainless steel tank cleaning and sterilization
Process/equipment development and optimization
Commissioning and qualification leadership
Nice-to-have
Industry trends and benchmarking
Data-driven insights and market intelligence
Partner management and leadership skills
Key Requirements
Bachelor's Degree in engineering (Chemical Engineering preferred)
Minimum of 10 years experience in aseptic drug product compounding in a biotherapeutics cGMP environment
Experience designing and implementing single-use technology
Experience designing stainless steel tanks and developing cleaning/sterilization recipes