Senior Associate Process Engineer

Senior Associate Process Engineer (Contract)

Elevate Bio – Waltham, MA – Contract – 6‑month term

Elevate Bio is a technology‑driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization.

The role is within the Manufacturing Science and Technology (MSAT) organization and will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross‑functional team.

• Work cross‑functionally across Process Development, Manufacturing, Quality, and Supply Chain to support technology transfers and cGMP manufacturing for clinical and commercial stage programs across modalities including cell and gene therapy, mRNA, and viral vector.
• Author and review technical documentation related to manufacturing activities including protocols, technical reports, work instructions, and SOPs.
• Own and support quality events such as deviations, investigations, CAPAs, and change controls.
• Assist in the root‑cause determination of process‑related deviations and propose comprehensive process solutions and improvements.
• Support gap analyses and risk assessments for capital projects and tech transfers.

• Bachelor’s Degree in Life Sciences, Engineering, Biotechnology, or a related discipline.
• 3 or more 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.
• Experience in cell and gene therapy, aseptic processing, and drug manufacturing preferred.
• 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.

$43/hour – $57/hour (budgeted range). This range is a good‑faith estimate based on qualifications, experience, and other factors.

Elevate Bio is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Elevate Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.