Process Validation Engineer CAR T

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Job Ref:

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

Position Summary
The 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 studies
* Provide 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 Regulatory
* Interface 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 goals
* Support the tracking of team metrics and manage completion of objectives and projects
* Participate in routine plant operating meetings Leadership:
* 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 :
* Expert knowledge of cGMP s and multi-national biopharmaceutical/cell therapy regulations
* 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)
* 5 or more years of manufacturing support or related experience in the biopharmaceutical industry #LI-POST

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: biological engineer, bioprocessing, enzyme, fermentation, hereditary, molecular, msat, neurodegenerative, parenteral, pathogenesis

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