Process Engineer, Principal Scientist – Automation of Machinery and Processes

## Process Engineer, Principal Scientist – Automation of Machinery and Processes Apply:
Boston, MA:
Full time:
Posted Yesterday:
REQ-30176
** Job Description
**** General

Summary:

** Vertex’s Automation of Machinery and Process (AMP) Team is seeking a Principal Process Engineer to develop cutting-edge manufacturing solutions for its Cell & Genetic Therapies programs. This pivotal role is at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. You will work with a passionate team of engineers, scientists, and innovators united by a shared mission: to push the boundaries of what’s possible in Cell & Genetic Therapy.

This position plays a critical role in leading cross-functional work streams for equipment & systems development, process optimization, and technology transfer to deliver robust and reliable manufacturing systems.
** Key

Duties and Responsibilities:

**
* ** Process & Systems Engineering Expertise:
** Provide technical leadership for the design, specification, selection, and lifecycle management of cell & genetic therapy process equipment and manufacturing systems, ensuring alignment with program objectives, business needs, regulatory requirements, and industry standards.
* ** Process Equipment & Manufacturing System Ownership:
** Serve as the principal subject matter expert for cell & genetic therapy process equipment and manufacturing systems during requirements definition, design reviews, commissioning, qualification, validation, and ongoing manufacturing support. Guide teams through complex technical decisions and issue resolution.
* ** Process & Equipment Optimization:
** Lead high-impact initiatives to improve equipment reliability, process robustness, operational efficiency, and scalability. Drive implementation of engineering solutions through structured problem-solving, risk assessment, and change management.
* ** Technical Delivery:
** Lead major engineering work streams and complex equipment development efforts from concept through implementation, including URS/FRS development, technology evaluations, RFP and vendor selection, facility & systems simulation, requirements mapping, safety risk assessments, FMEA execution, study design, FAT/SAT execution, technology transfer, and validation support. Collaborate with and manage external vendors to deliver systems on time and within budget.
* ** Troubleshooting and Manufacturing Support:
** Provide advanced hands-on technical support for equipment and manufacturing operations, including troubleshooting critical issues, supporting rapid development cycles, and enabling long-term manufacturing sustainability.
* ** Documentation and Compliance Excellence:
** Author, review, and approve technical documentation including protocols, reports, SOPs, work instructions, specifications, and engineering assessments, ensuring compliance with regulatory, quality, and internal standards.
* ** Cross-Functional Influence and

Collaboration:

** Partner closely with Manufacturing, Process Development, Quality, Validation, Facilities, MSAT, Project Management, and external vendors/partners to ensure successful delivery of engineering and equipment initiatives across the product lifecycle.
* ** Deviation, CAPA, and Change Control Leadership:
** Lead and support complex investigations, root cause analyses, deviation assessments, CAPA development, and change control activities. Ensure timely closure and sustainable corrective actions.
* ** Mentorship and Technical Development:
** Mentor junior engineers and contribute to the development of engineering best practices, standard work, and technical capabilities across the organization.
* ** Execution and Accountability:
** Deliver assigned objectives on time and…