Process Engineer, Principal Scientist – Automation of Machinery and Processes

Role: Principal Process Engineer leading automation and manufacturing solutions for Vertex's Cell & Genetic Therapies programs. Responsibilities include providing technical leadership on equipment/system design, lifecycle management, process optimization, and technology transfer; overseeing complex equipment development from concept to validation; troubleshooting manufacturing issues; authoring technical documentation; and collaborating cross-functionally with manufacturing, process development, quality, validation, and external vendors. Requirements include BS/MS in Engineering with 10+ years (or equivalent), extensive experience in process/systems engineering within regulated biotech environments, and knowledge of cell & gene therapy processes. Preferred skills encompass expertise in FMEA, risk assessment, cGMP/cGxP principles, and lean/six sigma methodologies. High-value specifics: focus on cell & genetic therapy manufacturing, equipment lifecycle management, regulatory compliance, and cross-functional leadership in a fast-paced, innovative setting. Location: On-site five days/week with ad hoc flexibility.