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Process Engineer I CAR T Project Support

Posted on Jun 23, 2019 by Celgene

Summit, NJ 07901
Immediate Start
Annual Salary
Req #:
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Organization: Manufacturing
Employee Status: Full-time
Job Type: Regular
Experience in biologic/vaccine manufacturing support, tech transfer, and validation

Position Summary Process Engineer I, CAR-T Project Support CAR-T Process Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Manages multidiscipline projects, creation/revision of engineering documentation and management of external resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products for both global clinical trials and commercial supply. Collaborates with SME from the Development Group, Manufacturing Group, and Quality Group while running cross functional internal project teams from initiation through project closeout (e.g. he/she is the primary internal and external contact regarding the day-to-day execution of the project) in support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Responsibilities include, but are not limited to, the following:
  • Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
  • Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)
  • Direct multidisciplinary project teams to ensure delivery of the project on time, on budget and to pre-defined quality level. Prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate progress, risks and status to project stakeholders and senior management
  • Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
  • Sponsor and support the change initiatives and the implementation of process improvement initiatives
  • Foster strong inter-team relationships to achieve common project goals
  • Interface with operations and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
  • Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
  • Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities
  • Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
  • Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
  • Interact with other teams including Validation, Development, Operations, QA and Regulatory
  • Support Director in accomplishing productivity and financial goals with the cross-functional team
  • Support the tracking of team metrics and manage completion of objectives and projects
  • Participate in routine plant operating meetings
  • Create an environment of teamwork, open communication, and a sense of urgency
  • Support the change agent in promoting flexibility, creativity, and accountability
  • Support organizational strategic goals and objectives that are linked to the overall company strategy
  • Drive strong collaboration within the plant and across the network
  • Build trust and effective relationships with peers and stakeholders
  • Deliver business results through timely and quality decision making and advice
  • Foster a culture of compliance and strong environmental, health, and safety performance
  • Promote a mindset of continuous improvement, problem solving, and prevention
Skills/Knowledge Required:
  • Knowledge of cGMP s and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus
  • Deep knowledge of facility/clean room design, process, equipment, automation, and validation
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Experience working with external parties and/or leading cross-functional teams
  • Possess strong verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Experience with Operational Excellence and Lean Manufacturing
  • Bachelor s Degree required (science or engineering is preferred)
  • 3 or more years of manufacturing support or related experience in the biopharmaceutical industry

About Us


At 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: bioinformatic, biomaterials, biomechanics, biomedical, biomedical engineer, bioprocess, molecular, pain, pharmaceutical, therapeutic

Reference: 724559185