Senior Process Engineer - Cell and Gene Therapy Systems

Vertex Pharmaceuticals; Boston (MA); On-site; USD 142,000 - 213,000; Full time

Job summary

Vertex's Automation of Machinery and Process (AMP) Team seeks a Principal Process Engineer to develop cutting-edge manufacturing solutions for cell and gene therapy programs. Lead cross-functional workstreams across equipment, systems, and process transfer to deliver robust manufacturing platforms.

You will guide complex technical decisions, manage external vendors, and mentor engineers while ensuring compliance with regulatory standards and quality systems.

Qualifications

• Cell & genetic therapy experience desired.
• Familiarity with cGMP/cGxP and 21 CFR Part 210/211 expectations.
• FMEA, root cause analysis, CAPA, and change control experience required.
• Ability to influence decisions across functions and levels.

Responsibilities

• Lead design, specification, and lifecycle management of process equipment and manufacturing systems.
• Own equipment and systems through qualification, validation, and manufacturing support.
• Drive process optimization, reliability, and scalability of manufacturing processes.
• Collaborate with cross-functional teams and external vendors to deliver projects on time and budget.
• Mentor junior engineers and contribute to engineering best practices across the organization.
• Ensure regulatory compliance and alignment with Quality System requirements.

Skills

Process & Systems Engineering

Technical Communication

Regulatory Knowledge

Problem Solving and Risk Management

Independence and Influence

Collaboration and Leadership

Execution Mindset

Education

BS or MS in Engineering or related technical discipline

Experience: 10+ years or MS 7+ years or PhD 4-7 years

Job description

Vertex's Automation of Machinery and Process (AMP) Team seeks a Principal Process Engineer to develop cutting-edge manufacturing solutions for cell and gene therapy programs. Lead cross-functional workstreams across equipment, systems, and process transfer to deliver robust manufacturing platforms.

You will guide complex technical decisions, manage external vendors, and mentor engineers while ensuring compliance with regulatory standards and quality systems.