Process Validation Engineer CAR T
Posted on: March 18, 2019
Process Validation Engineer CAR T Req #: Location: Summit, New Jersey, United StatesJob Category: Technical DevelopmentWork Location: 556 Morris Avenue 07901Organization: Manufacturing ServicesEmployee Status: Full-timeJob Type: Regular PREREQUISITES Experience in biologic/vaccine manufacturing support, tech transfer, and validationPosition SummaryThe Process Validation Engineer CAR-T is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Process Validation Engineer develops qualification/validation documents (e.g. protocols and reports) satisfying internal and external regulatory expectations. He/she perform independent execution of validation activities required for the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. Responsibilities include, but are not limited to, the following: Ensure safe and compliant cGMP operations.Maintain permanent inspection readiness and actively support regulatory inspections.Interface with operators and serve as validation SME. Learn the procedures, analytics and document any known sensitivity. Follow the facility validation policy and validation master plan.Support the Sr. Manager in the development and implementation of programs for the facility that ensure all aspects of the validation program are maintained in a state of compliance with respect to corporate and regulatory standards.Coordinate department validation activities within the production schedule. Develop the protocols for routine and extraordinary qualification, validation, re-qualification and revalidation of equipment and process.Conduct training for internal customers on protocols associated with equipment, systems, and processes under validation.Perform investigations associated to validation activities (e.g. deviations or OOS during validation studies).Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studiesProvide technical input and investigation support for production related investigations, ensuring compliance with validated state of the process.Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process.Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state of the process.Interact with other teams including Process Engineering and Support, Development, Operations, QA and RegulatoryInterface with regulatory authorities as required to support Manufacturing Operations audits.Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.Foster strong inter-team relationships to achieve common project goalsSupport the tracking of team metrics and manage completion of objectives and projectsParticipate in routine plant operating meetings Leadership: Create an environment of teamwork, open communication, and a sense of urgencySupport the change agent in promoting flexibility, creativity, and accountabilitySupport organizational strategic goals and objectives that are linked to the overall company strategyDrive strong collaboration within the plant and across the networkBuild trust and effective relationships with peers and stakeholdersDeliver business results through timely and quality decision making and adviceFoster a culture of compliance and strong environmental, health, and safety performancePromote a mindset of continuous improvement, problem solving, and prevention Skills/Knowledge Required : Expert knowledge of cGMP s and multi-national biopharmaceutical/cell therapy regulationsDeep knowledge of facility/clean room design, process, equipment, automation, and validationExperience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilitiesHands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologiesExperience working with external parties and/or leading cross-functional teamsPossess strong verbal/written communication skills and ability to influence at all levelsAbility to think strategically and to translate strategy into actionsAbility to prioritize and provide clear direction to team members in a highly dynamic environmentExperience with Operational Excellence and Lean ManufacturingBachelor s Degree required (science or engineering is preferred)5 or more years of manufacturing support or related experience in the biopharmaceutical industry#LI-POSTAbout UsCOMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDEAt Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. \"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: biochemistry, bioengineering, biomedical engineer, biophysics, bioprocessing, biosynthetic, enzyme, msat, neurodegenerative, pain
Keywords: Celgene, New York , Process Validation Engineer CAR T, Engineering , Summit, New York
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