Senior Associate Process Engineer

Responsibilities

• Provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects
• Author and review technical documentation including protocols, technical reports, work instructions, and SOPs
• Own and support quality events such as deviations, investigations, CAPAs, and Change Controls
• Assist in root cause determination of process-related deviations using scientific methodology
• Support gap analyses and risk assessments for capital projects and tech transfers
• Work cross-functionally across Process Development, Manufacturing, Quality, and Supply Chain

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, Biotechnology, or a related technical discipline
• 3+ years of experience in a MSAT, Manufacturing, or Process Development role
• Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
• Understanding of process development, validation, and lifecycle management
• Strong communication skills and ability to work cross-functionally
• Familiarity with electronic systems used in GMP environments such as Veeva or electronic batch records

Preferred Qualifications

• Experience in cell and gene therapy, aseptic processing, and drug manufacturing

About the Company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization through integrated technologies and manufacturing expertise.