Process Development Engineering Principal Scientist
Company: Vertex Pharmaceuticals
Posted on: June 25, 2022
Job DescriptionIn 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 Associate Director of Process
Engineering, this role will focus on the development of implantable
cell encapsulation devices for delivering proprietary cells. The
successful candidate will join the Process Development Team and
work on process development, optimization, process scale-up, and
technology transfer of novel products and processes into
Manufacturing. The position will be based out of Providence, RI.Key
- Design and development of equipment, processes, and control
systems, used for production and assembly of cell encapsulation
- Manage the evaluation and selection of new
equipment/technologies or modifications to existing systems to
consider new processing technologies.
- Support ongoing optimization and improvement in
equipment/systems/processes for long term robustness and
- Establishes operating specifications, defines process windows,
and improves manufacturing techniques/processes.
- 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.
- Statistically characterizes processes and implements controls
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, process, and manufacturing
assistance in support of a rapid development cycle and
- 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
- Support Deviation Management, CAPA, and Change Control
activities, as required.
- Performs other duties as assigned.Required Qualifications:
- BS or MS or PhD in engineering or another relevant
- BS and 10+ years of experience (8+ years with Masters, 4+ years
with PhD) working on process development and optimization within a
medical device environment or other GMP regulated industry.
- Experience leading and managing high-complexity new process
development initiatives from concept through execution, including
process documentation and process qualification.
- Experience acting as technical project manager and coordinating
cross-functional teams to achieve desired project results.
- 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
- Experience with 3D CAD software, preferably with Solidworks, is
- 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
- 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
- Must demonstrate strong interpersonal, presentation, and
teamwork skills.Company InformationVertex 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.Please note that Vertex requires
COVID-19 vaccination for all employees working in the U.S. as a
condition of employment at Vertex, subject to medical, religious or
other accommodations or exemptions required by law. We believe this
requirement is vital to keeping everyone at Vertex and in our
communities safe. This requirement applies to both existing and new
employees who may at any time work on-site at a Vertex facility or
visit another location on behalf of Vertex (e.g., conferences,
customer visits, etc.), including all remote employees. 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
Keywords: Vertex Pharmaceuticals, Providence , Process Development Engineering Principal Scientist, Engineering , Providence, Rhode Island
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