Manufacturing Science and Technology Principal Engineer, Equipment Qualification and Validation[...]

2 weeks ago


Boston, United States Vertex Pharmaceuticals Full time

Manufacturing Science and Technology Principal Engineer, Equipment Qualification and Validation (Cell & Gene Therapy) page is loaded

Manufacturing Science and Technology Principal Engineer, Equipment Qualification and Validation (Cell & Gene Therapy)

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locations

Boston, MA

time type

Full time

posted on

Posted 8 Days Ago

job requisition id

REQ-21454

Job Description Vertex MSAT team is seeking a Principal Engineer to join a growing team in support of commercial Cell and Gene Therapy programs. This position will be responsible for providing technical support in alignment with defined program priorities linked to drug substance and drug product with focus on process equipment design and qualification, process automation/robotics and digital data systems. Key Responsibilities: Identify and develop technical solutions to enable program and company goals. Contribute to the design and implementation of efficient and scalable manufacturing processes for commercial application, working closely with cross functional teams including process development, manufacturing, and engineering. The role includes the design and execution of process scale-up strategies and technologies, with the potential to design and implement novel equipment and manufacturing platforms for cell therapy programs. This includes the assessment of advanced automated systems, including robotics, artificial intelligence, and digital data systems. Establish process equipment selection and user requirement specifications to enable efficient facility installation and qualification. Drives continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial

robustness/reliability. Minimum Requirements : PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience. Significant experience with equipment FAT/SATs, qualification, and validation. Experience with large-scale GMP manufacturing for biopharmaceutical manufacturing, specifically facility design and process fit/transfer methodologies. Experience with process automation/robotics is preferred. Knowledge of vision or other automated inspection systems. Experience with cGMP regulations/guidance and with regulatory agency inspections preferred. Experience with inline process analytical technologies (PAT) for real time assessment of manufacturing performance is preferred. Experience working with external partners (CMOs, vendors, etc.). Ability to travel, nationally and internationally, up to 10 - 15%. Flexibility to work on site a minimum of 3 days per week. #LI-SV1 #LI-Hybrid 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. 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. Similar Jobs (5)

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Posted 30+ Days Ago Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and

transfusion-dependent

beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency

. 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, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit

www.vrtx.com

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. 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.

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