Senior GxP Site Engineer – Facilities & Compliance

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

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental, vision benefits

Generous PTO and commuting subsidy

Job summary

Vertex Pharmaceuticals is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for process, facility, instrumentation, and regulatory needs at Vertex GxP facilities. You will collaborate across Operations, Manufacturing, Project Engineering and QA to meet facility and manufacturing needs.

Role involves design reviews, lifecycle documentation, and leading continuous improvements. Requires a Bachelor's in engineering and 3–6 years in GxP engineering, with on-site

Qualifications

• Knowledge of cGMP and regulated facility design and change control.
• Experience with cell and gene therapy, OPS, or biologics facility design.
• Ability to read and interpret engineering drawings and perform calculations.

Responsibilities

• Collaborate with scientific groups to learn evolving science and tech.
• Execute change management for facility systems including commissioning.
• Support capital projects with science-based decisions and design reviews.
• Create and review system lifecycle docs (P&IDs, CQV docs, SOPs).
• Provide SME support for regulatory inspections and KPI monitoring.

Skills

GxP Engineering

Regulatory inspections

Capital projects

P&IDs and drawings

Change management

Education

Bachelor's degree in Chemical, Mechanical, or Electrical Eng

Job description

Vertex Pharmaceuticals is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for process, facility, instrumentation, and regulatory needs at Vertex GxP facilities. You will collaborate across Operations, Manufacturing, Project Engineering and QA to meet facility and manufacturing needs.

Role involves design reviews, lifecycle documentation, and leading continuous improvements. Requires a Bachelor's in engineering and 3–6 years in GxP engineering, with on-site