Vertex Pharmaceuticals · 23 hours ago
Senior Mechanical Design Engineer (Evergreen Contract)
Boston, MA
Contract
Hybrid
Senior Level
5+ years expVertex Pharmaceuticals is always looking for great talent, and they are seeking a Senior Mechanical Design Engineer to join their talent pool for upcoming opportunities. This role involves implementing industrial automation for medicinal modalities, focusing on machine and robotic design, and collaborating with various teams for technology transfer and continuous improvement.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Development of industrial automation used for production of medicinal modalities, including cell and gene therapy
Manage the evaluation and selection of new equipment/technologies or modifications to existing systems required for scale up
Machinery design and machinery design vendor management, including, but not limited to: kinematic design & analysis, dynamic analysis, stress analysis, tolerance stack analysis, mechanism design, cam-follower design, servo system design, robotic design, robotic end effector design, and stacker/de-stacker
Aseptic and GMP design. Design for cleanability and compatibility with cleaning agents. Single Use Set Design experience
Interface and collaborate with controls resources for joint electro-mechanical designs
Support optimization and improvement in equipment/systems/processes
Establishes equipment documentation, including parts lists, mechanical drawings, and assembly drawings. Provides engineering change documentation as appropriate
Executes and documents equipment commissioning activities including Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Supports equipment and process validation activities (IQ, OQ, PQ)
Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement
Statistically characterizes equipment performance and implements designs to ensure repeatability and consistency
Design and manage vendor design of 3D CAD models and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs
Create Equipment layouts in AutoCAD and/or Revit
Perform tolerance stack up calculations, GD&T, and create drawings to ASME Y14.5M-200977. Understand and apply other respective standards within machine design, including ANSI and ISO standards
Provide hands-on troubleshooting, equipment, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability
Execute assigned duties on time and within budget; proactively communicate delays and other issues to relevant stakeholders
Comply with all regulatory, corporate, and Quality System policies. Support Deviation Management, CAPA, and Change Control activities, as required
Performs other duties as assigned
Qualification
Required
BS or MS in engineering or another relevant discipline
5+ years of experience working within an automation development environment (pharmaceutical, cGxP preferred). Experience with cell & gene therapy is highly desirable
Experience working with a variety of automation hardware, including but not limited to, custom-fabricated mechanical components, cam systems, linkages, index and dwell machines, cartesian robots, SCARA robots, end of arm tooling, and dip coating
Experience validating manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous
Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products
Experience with 3D CAD software, preferably with Solidworks
Experience troubleshooting industrial automation
A strong understanding of statistical principles is required, as are strong technical writing and presentation skills
Hands-on approach to problem solving, risk identification and resolution
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously
Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management
Must demonstrate strong interpersonal, presentation, and teamwork skills
Role will require 3 days onsite between our Boston and Providence sites
Preferred
Six-sigma Green Belt / DMAIC problem solving experience preferred
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
2026-01-05
2026-01-05
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