Senior Associate Process Engineer (Contract)

ElevateBio • Waltham, MA

9d

About The Position

ElevateBio is seeking a Senior Associate Process Engineer within 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 across ElevateBio programs, working within a highly matrixed cross-functional team. The position also supports data collection and charting for non-GMP and GMP batches and prepares protocols, product impact assessments, root-cause analysis reports, and technical reports.

The Senior Associate Process Engineer works across 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. The role contributes to quality-event ownership and resolution, process-related investigations, risk assessments, and process improvement solutions.

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

• Provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects.
• Support technology transfers and cGMP manufacturing for clinical- and commercial-stage programs across cell and gene therapy, mRNA, and viral vector modalities.
• Author and review technical documentation, including protocols, technical reports, work instructions, and SOPs.
• Own and support quality events, including deviations, investigations, CAPAs, and Change Controls.
• Assist in determining root causes of process-related deviations in a timely and complete manner.
• Work with cross-functional teams to resolve complex problems using scientific methodology and technical reasoning, and propose process solutions and improvements.
• Support gap analyses and risk assessments for capital projects and technology transfers.
• Prepare product impact assessments and root-cause analysis reports.
• Support data collection and charting for non-GMP and GMP batches.

What This Job Offers

• Career Level: Senior