Hybrid Material Qualification Engineer for Biotech/Pharma

Real Staffing Group; Lexington (VA); Hybride; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health insurance

Health savings accounts

Retirement savings plans

Life and disability insurance

Paid leave

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Material qualification

Quality risk management

CAPA

Change controls

GMP investigations

Technical assessments

Formation

Bachelor's degree in material science or engineering

Master's degree with relevant experience

Outils

Single-use manufacturing equipment

Quality management systems

Description du poste

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