Process engineering principal scientific associate

Job Description

Process Dev Engineering Principal Scientific Associate

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, the Process Dev Engineering Principal Scientific Associate will be part of a team responsible for process development, equipment development, and optimization for implantable cell encapsulation devices. This position is based out of Providence, RI.

Key Responsibilities:

• Participates in development of upstream and downstream production processes
• Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability. Identifies automation opportunities, builds detailed project justifications, and executes projects accordingly.
• Establishes equipment documentation, commissioning protocols, operating specifications, equipment documentation, system manuals, preventative maintenance programs, spare parts lists, and improves manufacturing equipment.
• 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.
• Responsible for writing and reporting of Protocols, Reports, SOP’s, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities.
• Provide hands-on troubleshooting, equipment, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.
• Comply with all regulatory, corporate, and Quality System policies.
• Support Deviation Management, CAPA, and Change Control activities, as required.

Required Qualifications:

• BS or MS in engineering or another relevant discipline.
• Typically requires a Bachelor's degree and 5+ years of experience or a Masters degree and 1-3 years of experience or the equivalent combination of education and experience
• 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 .