Senior Associate Process Engineer (Contract)
About The Position
ElevateBio is seeking a Senior Associate Process Engineer in its Manufacturing Science and Technology (MSAT) organization. The role provides process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects for ElevateBio programs. The engineer works within a highly matrixed, cross-functional team and supports data collection and charting for non-GMP and GMP batches. The position also involves preparing protocols, product impact assessments, root-cause analysis reports, and technical reports. The role works with Process Development, Manufacturing, Quality, and Supply Chain to support technology transfers and cGMP manufacturing for clinical and commercial-stage programs across cell and gene therapy, mRNA, and viral vector modalities.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a related technical discipline.
- At least 3 years of experience in an MSAT, Manufacturing, or Process Development role.
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development.
- Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes.
- Strong communication skills and ability to work cross-functionally with technical and quality teams.
- Familiarity with electronic systems used in GMP environments, such as Veeva or electronic batch records.
Nice To Haves
- Experience in cell and gene therapy, aseptic processing, and drug manufacturing is preferred.
Responsibilities
- Work cross-functionally with Process Development, Manufacturing, Quality, and Supply Chain to support technology transfers and cGMP manufacturing for clinical and commercial-stage programs.
- Author and review technical documentation for manufacturing activities, including protocols, technical reports, work instructions, and SOPs.
- Own and support quality events, including deviations, investigations, CAPAs, and Change Controls.
- Assist with timely and complete root-cause determination for process-related deviations, working with cross-functional teams to resolve complex problems and propose process solutions and improvements.
- Support gap analyses and risk assessments for capital projects and technology transfers.
- Support data collection and charting for non-GMP and GMP batches.
- Provide process science support for development studies, characterization, validation, and continuous improvement projects.
- Prepare product impact assessments and root-cause analysis reports.
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What This Job Offers
Career Level
Mid Level
