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Advantage Technical

Process Engineer

Advantage Technical, Cambridge, Massachusetts, United States, 02140

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Position: Engineer II

Manufacturing Technical Services (MTS) Location:

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

MondayFriday, 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 Bachelors 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