Associate Director, Process Dev Engineering
Vertex Pharmaceuticals · Boston, MA
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Role summary
Vertex Pharmaceuticals seeks a Principal Process Engineer to lead automation and manufacturing systems development for cell and genetic therapy programs. The role requires technical expertise in equipment design, process optimization, and cross-functional collaboration to deliver robust manufacturing solutions in a regulated environment.
What they're looking for
- 10+ years of process/systems engineering experience, or 7+ with Master's degree, or 4-7 with PhD
- BS, MS, or PhD in Engineering or related technical discipline
- Proficiency in equipment development lifecycle from concept through validation and support
- Strong understanding of cGMP/cGxP principles, 21 CFR Part 210/211, and regulated manufacturing
- Expertise in FMEA, root cause analysis, CAPA, and change control methodologies
- Excellent technical writing and communication skills for diverse audiences
- Ability to operate autonomously, exercise sound judgment, and influence cross-functional decisions
What you'll be doing
- Lead design, specification, and lifecycle management of cell therapy process equipment and manufacturing systems
- Serve as principal subject matter expert for process equipment during design reviews, qualification, validation, and manufacturing support
- Drive high-impact initiatives to improve equipment reliability, process robustness, and operational efficiency
- Lead engineering workstreams including URS/FRS development, vendor selection, FAT/SAT execution, and technology transfer
- Author and approve technical documentation, protocols, and engineering assessments ensuring regulatory compliance
Privacy & handoff
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