Job Description

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

• Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related scientific field
• Minimum 2 years of hands-on lab or GMP manufacturing experience (academic lab experience considered)
• Experience with technology transfer and working with external manufacturing partners preferred
• Proficiency in Microsoft Word, Excel, and PowerPoint; experience with JMP or similar statistical tools is a plus
• Strong organizational, communication, and teamwork skills
• Ability to lift up to 50 lbs and adhere to lab safety standards
• Must be able to commute to both Cambridge and Norton, MA locations as needed

Preferred Experience

• Background in engineering or process development
• Experience executing lab investigations related to commercial manufacturing issues
• Exposure to device testing or cross-functional lab support
• Familiarity with GMP environments and regulated manufacturing practices

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