Manufacturing Quality Engineering and Validation Consultant

Responsibilities

• Provide quality oversight and support to Vertex Cell and Gene Therapy operations and capital projects.
• Support of manufacturing operations across all phases of development and commercial.
• Support of validation, analytical laboratory, materials management, and facility/engineering groups.
• Provide QA support of change controls, validation protocols, risk assessments, GMP investigations and CAPAs.
• Identify risks and communicate gaps for GMP process/systems.
• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications.
• Support EM and Routine testing of facilities and utilities and control programs (Client/EMS, pest control, etc.).

Requirements

• Experience providing QA support and oversight of GMP manufacturing operations and capital projects.
• Aseptic processing experience.
• Successfully leading event investigations, Root Cause Analysis and CAPA.
• Experience with network-based applications such as Veeva, Nuvolo, Viewlinc.
• Master's degree with 3-5 years of relevant work experience, or bachelor's degree in engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background.

Key Leadership Skills

• Collaboration / Teamwork / Conflict Management
• Results Driver

Key Knowledge/ Skills and Competencies

• The ability to thrive in a high throughput environment.
• Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.
• Ability to independently collaborate on cross-functional teams and represent the Quality unit.
• Ability to communicate effectively across all organizational levels.
• Critical Thinking / Problem Solving
• Attention to detail.