Job Description

In June 2019, Vertex announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy, and Type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT), our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities, to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Reporting to the Senior Manager of Automation Engineering, this role will implement industrial automation for implantable cell encapsulation devices. The successful candidate will join the Automation Engineering Team and 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 design.

Key Responsibilities:

• Co-development of industrial automation used for production and assembly of cell encapsulation devices.
• Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies.
• Support optimization and improvement in equipment/systems/processes.
• Assembled product machinery design; design for manufacturability; design for assembly; kinematic design & analysis; dynamic analysis; tolerance stack up analysis; mechanisms; cam-follower or servo systems; stress analysis.
• Establishes equipment documentation, including URS, FRS, FRA, parts lists, mechanical assemblies, drawings (with GD&T), 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 qualification 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 3D CAD models, create drawings, and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.
• 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 telegraph 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.

Required Qualifications:

• BS or MS in engineering or another relevant discipline.
• 8+ years of experience (5+ years with Masters) working within an automation development environment (medical device, cGxP preferred). Experience with device-biologic combination products 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 qualifying and validating manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to process development and validation are highly advantageous.
• Ability to coach and train less experienced engineers.
• 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, Solidworks or equivalent.
• Familiarity programming and troubleshooting industrial automation (Siemens PLC/HMI, Epson, Universal Robotics, PC-based systems, process instrumentation).
• 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.

Company Information