GxP Site Engineering Lead — On-site, GMP & Capex Expert

Scorpion Therapeutics; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Vertex seeks a GxP Site Engineering Senior Specialist to support engineering needs of its manufacturing facilities, covering process, facility, instrumentation, and regulatory aspects.

Responsibilities include collaboration with scientific and manufacturing teams, change control, capital projects oversight, and lifecycle documentation. Strong GMP knowledge and cross-functional communication are essential for success.

Qualifications

• Bachelor's in Chemical, Mechanical, or Electrical Engineering.
• 3–6 years of experience in GxP engineering with GMP knowledge.
• Familiarity with facility design for cell/gene therapy, biologics, or oral solid dose.

Responsibilities

• Collaborate with scientific and manufacturing teams and manage change control.
• Oversee capital projects and equipment design reviews and produce lifecycle documentation.
• Provide SME support for regulatory inspections and troubleshoot equipment and utilities.
• Drive continuous improvement in engineering services.

Skills

Reading drawings

Calculations

Regulatory compliance

Communication

Education

Bachelor's in Chemical, Mechanical, or Electrical Engineering

Job description

Vertex seeks a GxP Site Engineering Senior Specialist to support engineering needs of its manufacturing facilities, covering process, facility, instrumentation, and regulatory aspects.

Responsibilities include collaboration with scientific and manufacturing teams, change control, capital projects oversight, and lifecycle documentation. Strong GMP knowledge and cross-functional communication are essential for success.