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, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]