Material Qualification Engineer

Job Title: Material Qualification Engineer

Location: Lexington, MA 02421 (Hybrid)

Duration: 06 Months

Job Description:

• Support Material Qualification (MQ) activities for single-use components and QC-released raw materials across Client's biologics manufacturing processes, including tech transfer, change management, and lifecycle management.
• Develop, execute, analyze, and document MQ protocols, validation packages, technical assessments, and final reports, including support for deviations, CAPAs, GMP investigations, and change controls.
• Support Extractables & Leachables (E/L), Human Daily Exposure (HDE), quality risk assessments, and material qualification strategies to ensure product and patient safety.
• Required: Bachelor’s degree in Material Science, Mechanical, Biomedical, Chemical Engineering, or related field with 4+ years of relevant experience, or Master’s degree with 2+ years; pharmaceutical/biotech experience and mAb manufacturing knowledge preferred.
• Experience with single-use manufacturing components, material specifications/qualification, E/L assessments, and strong analytical, risk assessment, problem-solving, and cross-functional collaboration skills are required.