Material Qualification Engineer

A leading biologics manufacturing organisation is seeking a Material Qualification Engineer for a hybrid role based in Lexington, MA. The successful candidate will provide material qualification support across manufacturing sites, focusing on single-use components and QC-released raw materials. This position involves developing protocols, validation packages, and technical documentation to ensure compliance and patient safety, particularly regarding extractables and leachables assessments.

Key responsibilities include writing, executing, and summarising material qualification activities related to tech transfer, change management, and continuous lifecycle management. The engineer will develop and assess quality system elements such as risk management programs, CAPAs, change controls, deviations, GMP investigations, and vendor change notifications. The role also involves championing site projects involving QC-released chemicals and single-use raw materials, leading technical strategies, and representing material qualification in cross-functional teams and tech transfer activities.

The engineer will identify and implement opportunities for continuous improvement and best practices, and participate in the global material qualification community of practice. Occasional involvement in regulatory agency inspections is expected.

Candidates must have a bachelor's degree in material science, mechanical, biomedical, or chemical engineering (or a related field) with at least four years of relevant experience, or a master's degree with a minimum of two years' experience. Prior experience in the pharmaceutical or biotech industry, especially with monoclonal antibody manufacturing, is highly desirable. Familiarity with single-use manufacturing equipment, material specifications, and testing methods for quality attributes, leachables, and extractables is preferred.

Strong analytical, problem-solving, and project management skills are essential. The role requires close collaboration with quality assurance, quality control, supplier quality, supply chain, manufacturing, engineering, process development, validation, regulatory affairs, and facilities teams.

Must-Have

Skills:

material qualification, quality risk management, CAPA, change controls, GMP investigations, technical assessments

Nice-to-Have

Skills:

pharmaceutical industry, biotech industry, mAb manufacturing, single use manufacturing equipment, chemical specification, leachable, extractables, project management, data analysis, risk quantification

EOE Statement: Specialist Staffing Group 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 veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.