Process Engineer, Principal Scientist – Automation of Machinery and Processes

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 workstreams 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 workstreams 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 within budget while proactively identifying risks, escalating issues, and communicating impacts and mitigation plans to stakeholders and leadership. Quality and Regulatory Compliance: Ensure all activities are executed in accordance with applicable regulatory requirements, corporate policies, and Quality System expectations. Knowledge and Skills Process & Systems Engineering: Demonstrated proficiency leading complex equipment and manufacturing systems development initiatives from concept through implementation, including requirements definition, design, specification, documentation, commissioning, qualification, validation, and lifecycle support. Cell & genetic therapy experience desired. Technical Communication: Excellent technical writing, presentation, and communication skills, with the ability to clearly convey complex engineering concepts to technical and non-technical stakeholders. Regulatory Knowledge: Strong understanding of cGMP/cGxP principles and practices , including familiarity with 21 CFR Part 210 and 211 and applicable engineering and validation expectations in regulated manufacturing environments. Problem Solving and Risk Management: Expertise in utilizing structured problem-solving and risk-based decision-making to resolve technical challenges. Experience with FMEA, root cause analysis, CAPA, and change control is required. Lean/Six Sigma Green Belt or DMAIC experience preferred. Independence and Influence: Ability to operate with a high degree of autonomy, exercise sound engineering judgment, and influence decisions across functions and organizational levels. Collaboration and Leadership: Strong interpersonal and leadership skills with a demonstrated ability to manage multiple priorities, coordinate cross-functional and external contributors, and drive execution across complex programs. Execution Mindset: Strong sense of urgency, accountability, and proactive escalation, with the ability to balance strategic thinking and hands-on execution. Education and Experience Education: BS or MS in Engineering or a related technical discipline. Experience: Bachelor's degree and 10+ years of experience or a Master's degree and 7+ years of experience or a PhD and 4-7 years of experience, or the equivalent combination of education and experience . At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, a