Material Qualification Engineer

Real Staffing Group; Lexington (VA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plans

Life and disability insurance

Paid leave

Job summary

Real Staffing Group is seeking a Material Qualification Engineer for a hybrid role based in Lexington, MA. The successful candidate will support material qualification across manufacturing sites, focusing on single-use components and QC-released raw materials to ensure compliance and patient safety.

Responsibilities include developing protocols, validation packages, and technical documentation, and leading tech transfer and lifecycle management activities while collaborating across QA, QC, and

Qualifications

• Bachelor's degree in material science, mechanical, biomedical or chemical engineering with at least four years of relevant experience, or a master's degree with a minimum of two years' experience.
• Experience in the pharmaceutical or biotech industry is highly desirable, especially monoclonal antibody manufacturing.
• Familiarity with single-use equipment, material specifications, and testing methods for quality attributes, leachables and extractables.

Responsibilities

• Write, execute, and summarise material qualification activities related to tech transfer, change management, and continuous lifecycle management.
• Develop protocols, validation packages, and technical documentation to ensure compliance and patient safety.
• Champion site projects involving QC-released chemicals and single-use raw materials, leading technical strategies.
• Collaborate with QA, QC, supplier quality, supply chain, manufacturing, engineering, process development, validation, regulatory affairs, and facilities teams.
• Identify opportunities for continuous improvement and best practices; participate in global material qualification community of practice.

Skills

Material qualification

Quality risk management

CAPA

Change controls

GMP investigations

Technical assessments

Education

Bachelor's degree in material science or engineering

Master's degree with relevant experience

Tools

Single-use manufacturing equipment

Quality management systems

Job description

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.