Process Engineer, Principal Scientist – Automation of Machinery and Processes

Vertex Pharmaceuticals Inc (US); Leiden; On-site; EUR 123,000 - 185,000; Full time

Job summary

Vertex Pharmaceuticals Inc seeks a Principal Process Engineer to advance automated manufacturing for cell & gene therapies. You will lead equipment and systems development, drive risk assessment, and guide technology transfer across programs.

You will own end-to-end execution, ensure regulatory compliance, and mentor junior engineers while partnering with Manufacturing, Quality, Validation, and external vendors to deliver robust manufacturing solutions.

Qualifications

• BS or MS in Engineering or related technical discipline with 10+ years of experience, or a PhD with 4–7 years.

Responsibilities

• Lead design, specification, and lifecycle management of cell & genetic therapy process equipment and systems.
• Own major engineering workstreams from concept through validation and tech transfer.
• Mentor engineers and drive cross‑functional collaboration across Manufacturing, QA, and Validation.

Education

BS or MS in Engineering or related technical discipline

Job description

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

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 [e-mail].

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion‑dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1‑mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH‑dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry’s top places to work, including 16 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X.

We believe our culture is one of Vertex’s greatest strengths

Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.