GxP Site Engineering Senior Specialist
Core
Senior engineering specialist supporting GxP facility design, equipment lifecycle, and regulatory compliance for Vertex's biopharmaceutical manufacturing sites.
Role type
Senior IC GxP Site Engineering Specialist
Builds
GxP-compliant pharmaceutical manufacturing facilities and equipment infrastructure
Domain
Biopharmaceuticals / GxP Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP and regulated facility design, change control processes, commissioning and qualification, validation, pharmaceutical industry best practices, Cell and Gene Therapy facility design, Oral Solid Dose facility design, Biologics facility design, engineering drawing interpretation (P&IDs, I&C Diagrams), engineering calculations, MEP engineering principles, GMP manufacturing regulations (FDA 21 CFRs)
Preferred skills
Mechanical abilities (tool familiarity, lifting, ladder climbing, cleanroom gowning), adaptability to change, self-management
Technologies
P&IDs, I&C Diagrams, Electrical Panel Schedules
Responsibilities
Collaborate with scientific groups to understand evolving science and technology; execute change management for facility and support systems; implement science-centric strategic decisions for capital projects; participate in design reviews for capital projects and new equipment; create and review system lifecycle documentation (drawings, P&IDs, CQV documents, SOPs); perform engineering assessments for new capital equipment/projects; provide SME support for regulatory inspections; lead troubleshooting of process and facility equipment; monitor and report Engineering KPIs.
Seniority
Senior, hands-on IC
