Material Qualification Engineer

Material Qualification Engineer (Contract) Location: Cambridge, MA (Hybrid, onsite Tuesday through Thursday) Nature and Scope of Job The Material Qualification Engineer will provide material qualification (MQ) support for a biologics manufacturing operation in the Cambridge, MA area. This individual will develop and execute MQ strategies for single use components and QC released raw materials across commercial manufacturing processes, support patient safety programs through extractables and leachables assessments, and partner with cross-functional teams to ensure material qualification requirements are built into routine site business processes. Primary Responsibilities Material Qualification Execution (approximately 75%) Develop MQ protocols, reports, and supporting documentation for single use components and QC released raw materials used across manufacturing processes. Build MQ validation packages, including acquiring necessary data and summarizing results into final reports. Write, execute, analyze, and summarize MQ activities supporting tech transfer and new product introduction, change management, and continuous lifecycle management. Support the Human Daily Exposure (HDE) program, including technical assessments and extractables and leachables (E&L) calculations to ensure patient safety for commercial drug substance. Provide MQ technical, compliance, and quality support to tech transfer teams as required. Develop and assess Quality System elements for material qualification, including Quality Risk Management, CAPAs, change controls, deviations, GMP investigations, and vendor change notifications. Perform technical assessments of proposed changes to validated process components to identify requirements needed to maintain validated status. Lead development of technical strategy for MQ activities and champion site projects involving QC released chemicals and single use raw materials. Own MQ Quality System records as required and manage projects through closure within established timelines. Cross-Functional Collaboration Represent MQ in meetings and strategy discussions with operations, engineering, quality, MSAT, and new product introduction teams. Interface with procurement, quality, manufacturing, engineering, compliance, and process development to communicate material qualification requirements and integrate them into routine business processes. Partner with Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Process Development, Process Validation, Regulatory Affairs, and Facilities to execute MQ studies and projects. Continuous Improvement and Inspection Support Identify and implement opportunities for continuous improvement and adoption of best practices (approximately 20%). Represent the site MQ function within a global MQ community of practice. Participate in regulatory agency inspections for material qualification (approximately 5%). Required Qualifications Bachelor’s degree in Material Science, Mechanical, Biomedical, or Chemical Engineering, or a related science or engineering field, with a minimum of 4 years of relevant experience, or a Master’s degree in a related field with a minimum of 2 years of relevant experience. Ability to analyze data, quantify risks, and identify gaps independently. Ability to exercise sound judgment within defined procedures and practices to determine appropriate action. Ability to propose solutions to problems and elevate issues with recommended solutions to management as needed. Strong written communication skills for protocols, technical assessments, and reports. Preferred Qualifications Prior experience in the pharmaceutical or biotech industry, including monoclonal antibody (mAb) manufacturing knowledge, upstream or downstream. Knowledge of single use manufacturing equipment design and single use and chemical specification and qualification. Familiarity with major material suppliers, standards for material selection, and methods for testing quality attributes, including extractables and leachables. Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Work onsite in Cambridge, MA three days per week, Tuesday through Thursday, with remaining days remote. Work in a GMP manufacturing environment and follow all site safety and gowning requirements as applicable. Operate standard office productivity equipment, including a computer, phone, scanner, and printer. Frequently communicate with stakeholders via telephone, video conference, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Compensation Hourly Pay Rate: USD USD 55.00 to 72.00 per hour (W2) The pay range represents the anticipated low and high end of USDM’s compensation range for this position. Actual pay rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. #J-18808-Ljbffr USDM Life Sciences