Temporary Manufacturing Operations Associate Technician
About the Job
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 Operation.
- 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 required.
- Review all Manufacturing Documentation, including Assembly, Inspection, Test, and Packaging Procedures, and provide feedback.
- High School Diploma or equivalent; Technical Education preferred.
- 2+ Years Manufacturing Work Experience in a Medical Device and / or other Regulated Environment; strong familiarity with c.G.M.Ps..
- Manual dexterity to handle tools, and other equipment, of varying sizes
- 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 required.
- Experience in assembly of small, intricate Components under microscopic guidance.
- Familiarity with E.R.P. and Laboratory Information Management Systems.