What are the responsibilities and job description for the Manufacturing Engineer position at Advantage Technical?
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
