GxP Site Engineering Senior Specialist

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

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.