Process Engineer, Principal Scientist – Automation of Machinery and Processes

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 142,000 - 213,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical insurance

Dental insurance

Vision benefits

Paid time off

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals LLC is seeking a Principal Process Engineer to drive automation of cell and genetic therapy manufacturing. You will lead design, qualification, and validation of process equipment, partnering with Manufacturing, Process Development, Quality, and external vendors to deliver robust systems.

The role emphasizes cross-functional leadership, regulatory compliance, and pipeline-wide process optimization, with a focus on safety, reliability, and scalable manufacturing solutions

Qualifications

• BS or MS in Engineering or related field.
• 10+ years of relevant experience.
• Experience with cGMP/cGxP and regulatory standards.

Responsibilities

• Lead design, specification, and lifecycle management of cell & genetic therapy process equipment and manufacturing systems.
• Own requirements definition, design reviews, commissioning, qualification, and validation activities.
• Drive process optimization, equipment reliability, and technology transfer across programs.
• Provide mentorship and technical leadership to junior engineers and cross-functional teams.
• Ensure documentation, quality, and regulatory compliance across projects.

Skills

Process engineering

cGMP/cGxP knowledge

Regulatory knowledge

Risk assessment

Leadership

Education

BS or MS in Engineering

PhD beneficial

Job description

## Process Engineer, Principal Scientist – Automation of Machinery and ProcessesApply: 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 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:**$141,800 - $212,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**On-Site Designated**Flex Eligibility Status:**In this **On-Site** designated role, you will work **five days per week on-site** with ad hoc flexibility.