Process Engineer

Position : Engineer II – Manufacturing Technical Services (MTS)

Location : Cambridge, MA (with travel to Norton, MA as needed)

Schedule : Monday–Friday, 9 : 00 AM – 5 : 00 PM | 100% Onsite

Position Overview

A leading biopharmaceutical company is seeking a Manufacturing Technical Services Engineer II to support late-stage and commercial drug product manufacturing. This role is focused on technology transfer, process validation, and continuous improvement initiatives to ensure robust, compliant, and efficient production of RNA-based therapeutics. The position is lab-based and will involve collaboration across technical and operational teams.

Key Responsibilities

• Support technology transfer, process scale-up, and optimization activities at Contract Manufacturing Organizations (CMOs)
• Assist with deviation assessments, change control documentation, CAPA development, and risk evaluations
• Collect, analyze, and interpret process data; prepare technical summaries and reports
• Contribute to process validation, investigations, and continuous improvement efforts
• Author and revise process control documents; communicate updates to cross-functional teams
• Conduct lab experiments and small-scale studies to support development and technical investigations
• Collaborate with internal teams and external partners to ensure alignment on manufacturing strategies

Qualifications

Preferred Experience