Process Dev Senior Engineer

Job Description 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 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 Senior Manager of Process Engineering, this role will lead and manage process development projects for implantable cell encapsulation devices with a focus on materials and plastic processes. The successful candidate will join the Process Development Team and support process development, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. The position is based out of Providence, RI. Key Responsibilities: Work as part of the Process Development Team to create and implement new manufacturing processes for cell encapsulation devices. Perform Design of Experiments to define and optimize equipment parameters for new and/or existing processes. Create documentation to support new and improved manufacturing processes. Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’ Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements for processes such as assembly, joining, and staking. Lead plastics/material vendor activities including design for manufacturing (DFM) analysis, mold/tool design and analysis, process development, troubleshooting, and validation of injection molding and other plastics/material processing technologies. 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, SOPs, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities. Statistically characterizes processes and implements control to ensure repeatability and consistency. Provide hands-on troubleshooting, process, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability. 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 policies. Support Deviation Management, CAPA, and Change Control activities, as required. Performs other duties as assigned. Required Qualifications: BS or MS in Plastics, Material Science, Mechanical, Biomedical, or other related engineering degrees. Minimum of 8 years work experience (5 years with Masters) working on process development and optimization within a medical device or other GMP-regulated industry. Experience leading and managing new process development initiatives from concept through execution, including process documentation and process qualification. Understanding of plastics processing including injection molding and mold design Hands-on approach to problem-solving, risk identification, and resolution. A strong understanding of statistical principles is required Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management. Must be able to work independently with minimal supervision, multi-task, and support several projects simultaneously. Must demonstrate strong interpersonal, presentation, and teamwork skills. Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Previous experience in the areas of Technology/Process Transfer, Process Validation, Design for Manufacturing (DFM), Lean Manufacturing, Process Control Concepts, Design of Experiments (DoE), and product/process Failure Mode and Effects Analysis (FMEA) Experience with polymer joining (thermal staking, ultrasonic / laser welding), polymer processing (injection molding), and coating is a plus. Experience with 3D CAD software (such as Solidworks) is a plus Six-sigma Certificate and/or DMAIC problem-solving experience. Company Information Vertex 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 ApplicationAssistance@vrtx.com. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune’s Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.