QE Execution Specialist, Manufacturing Ops

Vertex Pharmaceuticals LLC; Boston (MA); Presencial; USD 47.000 - 92.000; Jornada completa

Descripción de la vacante

Vertex Pharmaceuticals LLC is seeking a staff member for the MTO Engineering Operations in Boston to own and execute quality records such as deviations, CAPAs, change controls, and investigations across manufacturing and QC functions.

The role emphasizes data review, root cause analysis, GEMBA, project management, and collaboration with SMEs, with shifts based on the hiring manager. This is an on-site position in Boston.

Formación

• Senior level requires engineering degree with 5+ years in engineering, project management and pharmaceutical experience.
• Mid level requires engineering degree with 2-5 years' work experience in industry.
• Junior level requires engineering degree with 0-1 year experience and eagerness to learn.

Responsabilidades

• Involved in deviation triage including coordination and investigational planning and event initiation.
• Lead investigations for manufacturing, QC, material, facility and equipment deviations using root cause analysis tools.
• Own and drive CAPAs, change controls and QE records in eQMS, ensuring timelines and due dates are met.
• Collaborate with SMEs to determine root cause and propose corrective and preventive actions.

Conocimientos

Project management

Pharma experience

Educación

Engineering degree

Descripción del empleo

Vertex Pharmaceuticals LLC is seeking a staff member for the MTO Engineering Operations in Boston to own and execute quality records such as deviations, CAPAs, change controls, and investigations across manufacturing and QC functions.

The role emphasizes data review, root cause analysis, GEMBA, project management, and collaboration with SMEs, with shifts based on the hiring manager. This is an on-site position in Boston.