GxP Site Engineering Senior Specialist

Role: GxP Site Engineering Senior Specialist responsible for supporting engineering needs of Vertex's GxP manufacturing facilities, including process, facility, instrumentation, and regulatory aspects. Responsibilities: collaborate with scientific and manufacturing teams, manage change control, oversee capital projects and equipment design reviews, produce and review lifecycle documentation, provide SME support for regulatory inspections, troubleshoot equipment and utilities, and drive continuous improvement in engineering services. Requirements: Bachelor's in Chemical, Mechanical, or Electrical Engineering; 3-6 years in GxP engineering with knowledge of GMP, facility design (cell/gene therapy, biologics, oral solid dose), and industry standards (GMP, ISO, GAMP). Skills include reading engineering drawings, performing calculations, understanding regulatory compliance, and effective communication. Preferred: experience in regulated facility design, especially in cell and gene therapy or biologics. High-Value: GxP facilities, GMP compliance, regulated manufacturing, capital project design, lifecycle documentation, and cross-functional collaboration with R&D, manufacturing, QA, and project teams. Work setup: on-site five days/week with ad hoc flexibility.