Vertex Pharmaceuticals

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:

• Technical Project Management, including the development of schedules, resource requirements, and communication dashboards.
• Co-development of industrial automation used for production and assembly of cell encapsulation devices.
• Support optimization and improvement in equipment/systems/processes.
• Control System Design of Assembled product machinery; design for manufacturability; design for safety.
• System design, including technology selection, vendor selection, URS, FRS, design documents, and cross-functional technical coordination.
• Identify and manage vendors to assist in industrial automation solutions. Experience working with panel build vendors and industrial machinery integrators.
• Perform Failure Mode Analysis as input to design; creates failsafe designs for critical processes.
• Robotic programming, including, but not limited to SCARA robots.
• PLC programming utilizing Allen Bradley and Siemens.
• Integrate machine vision into industrial applications.
• Design and implement Engineering Safeguards including, but not limited to guarding, light curtains, E-Stops, and Safety Circuits.
• Design and Document Safety Circuit Performance Levels according to ISO 13849-1:2023.
• Follow relevant standards, such as NFPA 70 and 79.
• Electrical Power Panel Design, including Short Circuit Current Rating single line diagrams.
• Equipment debug, including the use of oscilloscopes, PLC trending, and high speed video.
• Establishes equipment documentation, including parts lists, electrical drawings, and pneumatic 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.
• Create or manage the creation of schematics in AutoCAD.
• 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, cam systems, linkages, index and dwell machines, servo systems, cartesian robots, SCARA robots, and end of arm tooling.
• 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.
• Familiarity working with and troubleshooting industrial automation (Siemens PLC/HMI, Epson, Universal Robotics, PC-based systems, process instrumentation). PackML programming experience preferred.
• 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

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 ApplicationAssistance@vrtx.com.