Elevatebio

Senior Associate Process Engineer (Contract)

Waltham, Massachusetts, United States · Senior

Sponsorship not specifiedDetected 40 days ago

Supply ChainGMPCRISPRCell CultureCommunication

About the role

ElevateBio is looking for a Senior Associate Process Engineer within the Manufacturing Science and Technology (MSAT) organization.
Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, work instructions, SOPs.
Assist in the root cause determination of process-related deviations in a timely and complete manner.

Work cross-functionally across Process Development, Manufacturing, Quality, and Supply Chain to provide support for technology transfers and cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral vector.
Own and support quality events such as deviations, investigations, CAPAs, and Change Controls.
Support gap analyses and risk assessments to support the capital projects and tech transfers.
You will additionally support data collection and charting for non-GMP and GMP batches.

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
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
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

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

As part of support, you will write protocols, product impact assessments, root-cause analysis reports, and technical reports.

This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.