Senior Mechanical Design Engineer (Evergreen Contract)

Vertex Pharmaceuticals•Boston, MA

1d•Hybrid

About The Position

Join Our Talent Pool - We're always looking for great talent! Apply now to join our talent pool for upcoming Mechanical Design Engeeing opportunities. Senior Mechanical Design Engineer Reporting to the Associate Director of Automating Equipment & Processes, this role will implement industrial automation for a range of medicinal modalities, including cell and gene therapy. The successful candidate will join the Automating Equipment & Processes Group to work on automation development, commissioning, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. This role will focus on machine and robotic design.

Requirements

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. Six-sigma Green Belt / DMAIC problem solving experience preferred.
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.

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.