Senior Manager, Process Engineering
Company: Vertex Pharmaceuticals
Posted on: September 16, 2020
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 treatand even
cureseveral 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 Vertexs continued and
sustained leadership in these exciting approaches. At Vertex Cell
and Genetic Therapies (V.C.G.T.), 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 Director of Process Engineering, this individual
will be responsible for developing and executing the Process
Engineering strategy relating to the design and development of
medical devices intended to encapsulate a novel cell therapy for
the treatment of Type 1 Diabetes. In addition, he/she will provide
leadership in overseeing process validation, technology transfer,
and implementation of continuous improvement initiatives. It is
also expected that the incumbent will provide Engineering support
to other groups, including R&D and manufacturing, as required.
The position is based out of Providence, R.I.
- Develop process optimization/scale-up strategy and drive
engineering initiatives to meet department and organizational
objectives as the company prepares to begin clinical
- Lead a team of process engineers involved in the design and
development of equipment, processes, and control systems, used for
production and assembly of cell encapsulation devices.
- Provide technical engineering expertise within multiple areas
of responsibility, including engineering, validation, packaging,
sterilization, and equipment/system development.
- Ensure the development of detailed project plans and timelines,
including resource and equipment needs, budgets, outside
contractors, purchased equipment, and materials. Present to Senior
Management as required.
- Manage the evaluation and selection of new
equipment/technologies or modifications to existing systems to
consider new processing technologies or strategies. This may
include economic, quality, and productivity analysis.
- Responsible for ongoing optimization and improvement in
equipment/systems/processes for long term robustness and
- Establishes operating equipment specifications, defines process
windows, and improves manufacturing techniques/processes.
- Provide technical engineering oversight from development to the
transfer and implementation and routine operation of process
- Statistically characterizes processes and implement controls to
ensure repeatability and consistency.
- Support deviation management, CAPA, and change control
activities, as required. Serve as process S.M.E. to Quality, Supply
Chain, Manufacturing, and other Functions. Support manufacturing
investigations, including OOSs., OOTs., RCAs., etc.
- Authors protocols, pFMEAs, equipment and process documentation,
SOPs, and work instructions in compliance with VCGT quality
management systems and industry regulations.
- Coordinates activities of the department and with other
- Performs other duties as assigned.
- Bachelor's or Master's Degree in engineering or another
- Minimum of 10 years of experience working within a medical
device environment, with a minimum of 4 years in a managerial
capacity. Experience with device-biologic combination products is
- Proven experience with Process Development, Process
Optimization, Scale-up, and Technology Transfers.
- Strong understanding of Process Instrumentation and
- Comprehensive knowledge of Design Control and Risk Management,
including experience using F.M.E.A. analyses, is strongly
- A thorough understanding of c.G.x.P principles and practices,
ISO 13485, ISO 14971, and 21C.F.R.820.
- A strong understanding of statistical principles is required,
as are strong technical writing and presentation skills.
- Must be able to work independently with adequate supervision,
multi-task, and support several projects simultaneously.
- Must demonstrate strong interpersonal, teamwork, and team
- Ability to organize a team through organizational changes
Keywords: Vertex Pharmaceuticals, Providence , Senior Manager, Process Engineering, Engineering , Providence, Rhode Island
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