Senior GxP Site Engineer — Facilities & Compliance

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 104,000 - 156,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a GxP Site Engineering Senior Specialist to drive process, facility, instrumentation, and regulatory needs at Vertex GxP Facilities. You will collaborate across Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams, and Site Leadership to meet manufacturing objectives.

The role includes design reviews, lifecycle documentation, and support for regulatory inspections, with a focus on continuous improvement of

Qualifications

• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering or related field.
• Typically requires 3–6 years of relevant GxP Engineering experience or equivalent.
• Knowledge of cGMP, regulatory compliance, and facility design best practices.

Responsibilities

• Represent Global Engineering for process, facility, instrumentation, and regulatory needs.
• Collaborate with Facilities Operations, Advanced Manufacturing Engineering, and others.
• Participate in design reviews for capital projects with focus on cost, efficiency and compliance.
• Create, revise, and review lifecycle documentation (drawings, P&IDs, CQV docs, SOPs).
• Provide SME support for regulatory inspections from facility design and engineering standpoint.
• Lead troubleshooting of process and facility equipment and utilities; monitor KPIs.

Skills

cGMP knowledge

Regulatory compliance

P&IDs understanding

Capital projects

Cross-functional collaboration

Reading engineering drawings

Facility design knowledge

Education

Bachelors in Chemical/Mechanical/Electrical Engineering

Job description

Vertex Pharmaceuticals Incorporated is seeking a GxP Site Engineering Senior Specialist to drive process, facility, instrumentation, and regulatory needs at Vertex GxP Facilities. You will collaborate across Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams, and Site Leadership to meet manufacturing objectives.

The role includes design reviews, lifecycle documentation, and support for regulatory inspections, with a focus on continuous improvement of