Manufacturing Quality Engineering and Validation Consultant

The Quality Engineering and Validation Consultant is recognized as an expert internally in the principles and application of quality assurance and compliance. This position coordinates GMP activities in support of clinical and commercial Drug Product manufacture. This position reports to Associate Director GMP Quality - Cell & Gene. This is an onsite Monday through Friday position.

• 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
• As part of the VCGT GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations and capital projects in the following key areas/activities; 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.
• Responsible for identifying risks and communicating gaps for GMP process/systems
• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
• Review and approval of trending programs (equipment, facility, utilities, etc.)
• Support EM and Routine testing of facilities and utilities and control programs (BMS/EMS, pest control, etc.)