Temporary Manufacturing Operations Associate Technician
Company: Vertex Pharmaceuticals
Posted on: February 20, 2021
In June 2019, Vertex announced the establishment of a new
research site in the Boston area 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.
This role will focus on the fabrication of cell encapsulation
devices for delivering proprietary cells, including manufacturing
of all components and final assembly of the finished device. The
Successful Candidate will join the Device Manufacturing Team and
work closely with the Device Process Development, Device Quality
Control, and Device Quality Assurance Functions, as required. The
position will be located in Providence, R.I..
* Execute daily maintenance and startup activities of all
manufacturing Unit Operations.
* Manufacture and assemble Medical Devices in an ISO 7/8
Environment, ensuring compliance with c.G.M.P.
* Procedures and all Cleanroom Practices in each Unit
* Complete and compile Batch Records in a manner that complies with
c.G.M.Ps. / c.G.D.Ps., and all relevant Procedures.
* Comply with all Company Policies including Health, Safety, and
Environmental Regulations, Personal Protective Equipment
Requirements, and Standard Operating Procedures.
* Ensure upkeep of Manufacturing Areas to allow for a clean, safe,
and organized Work Environment.
* Review and train to Work Instructions and other relevant
documents on an as-needed basis.
* Prioritize and plan work activities, and adapt to changing
Production Schedules and other conditions, as required.
* Participate in Process Capability Assessments, Process Validation
Activities, Root Cause Investigations, Corrective and Preventative
Actions, Physical Inventory, Cycle Counts, Variance Investigation
and Reconciliation, and other Cross-Functional Activities, as
* Review all Manufacturing Documentation, including Assembly,
Inspection, Test, and Packaging Procedures, and provide
* High School Diploma or equivalent; Technical Education
* 2+ Years Manufacturing Work Experience in a Medical Device and /
or other Regulated Environment; strong familiarity with
* Manual dexterity to handle tools, and other equipment, of varying
* Excellent verbal and written communication; demonstrable English
reading and writing skills.
* Proven ability to monitor own Work Product, ensuring quality,
accuracy, and thoroughness; able to self-motivate and work
independently or as part of a larger Team.
* Ability to work in a fast-paced environment and multi-task;
comfortable with changing Work Environments and priorities.
* Flexible to work overtime, extended hours, and weekends, as
* Experience in assembly of small, intricate Components under
* Familiarity with E.R.P. and Laboratory Information Management
Keywords: Vertex Pharmaceuticals, Providence , Temporary Manufacturing Operations Associate Technician, Professions , Providence, Rhode Island
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