Product Development Engineer Senior Specialist
JOB TITLE: Product Development Engineer Senior Specialist
LOCATION: 225A Carolina Avenue, Providence, RI 02905
DUTIES: Position will be responsible for offering a high level of technical leadership to process development and optimization, as well as for the characterization of cell encapsulation devices for ongoing and future projects; contribute to the exploration of NextGen technologies and establishment of new technologies; contributes to development of robust, scalable manufacturing processes for devices used in cell and gene therapies; lead process optimization in the support of process scale-up and scale-down models; evaluate novel and emerging technologies to advance project strategies; participate in technology transfer to CMO and provides manufacturing oversight for GMP production; apply relevant principles to process characterization, establishes process parameters, and contributes to CMC sections of regulatory filings; effectively collaborate with a fully integrated team to facilitate the success of projects; expanded conceptual knowledge and understanding of principles of wound healing and molecular and cell biology techniques; apply fundamental scientific and engineering principles to process design, development, and process understanding; and, apply statistical principles to guide process optimization. Travel required up to 10%.
REQUIREMENTS: Position requires a Bachelor’s degree (or foreign equivalent) in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Biological Sciences, or a related field plus six (6) years of experience in the job offered or in a related occupation. Alternatively, employer will accept a Master’s degree (or foreign equivalent) in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Biological Sciences, or a related field plus three (3) years of experience in the job offered or in a related occupation. Experience must include the following: • Demonstrable experience with process scale-up: including determination of cost of goods for manufacturing, management of contract manufacturers, development and validation of cleaning and assembly processes, equipment qualification, and optimization of in-process test methods; • Demonstrable experience with product development: Including design controls, risk analysis, and failure modes and effects analysis (FMEA); • Demonstrable experience with technology transfer; • Demonstrable experience with process transfer: Including cleanroom packaging and process development and validation and test method development; • Demonstrable experience with manufacturing oversight; • Demonstrable experience with statistical analysis and process optimization; • Demonstrable experience with manufacturing process and material flow; • Demonstrable experience with contributing to manufacturing sections within regulatory filings; • Demonstrable experience with CAD 3D modeling and drawings; • Demonstrable experience with Root Cause Investigations, CAPA’s, and change control; and, • Demonstrable experience with cGxP principles and practices, ISO 13485, ISO 14971, 21CFR.820. Travel required up to 10%.
CONTACT: Send Resume to Jessica Farley at Jessica_Farley@vrtx.com. Reference 12140.422. EOE.
Vertex is a global biotechnology company that invests in scientific innovation.
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